
==== Front
Clin Spine Surg
Clin Spine Surg
BSD
Clinical Spine Surgery
2380-0186
2380-0194
Lippincott Williams & Wilkins Hagerstown, MD

38446588
CSS-23-292
10.1097/BSD.0000000000001586
00010
3
Primary Research
Does Epidural Corticosteroid Application During Spinal Surgery Reduce Postoperative Pain?: An Adjunct to Multimodal Analgesia
Song Hyun BS 99hyunsong@gmail.com

Edwards Charles II MD caedwards20@gmail.com

Curto Ryan BS ryancurto@icloud.com

Perez Alejandro BS aperez.hob@gmail.com

Cruess Cailin BS cailincruess@gmail.com

Schell Adam MD adam.j.schell@gmail.com

Park Justin MD juspark1@gmail.com

Maryland Spine Center, Mercy Medical Center, Baltimore, MD
Reprints: Charles Edwards II, MD, The Maryland Spine Center, 301, St. Paul Place, Baltimore, MD 21202 (e-mail: caedwards20@gmail.com).
10 2024
5 3 2024
37 8 E354E363
4 8 2023
22 1 2024
Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.
2024
https://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0/

Study Design:

A prospective, randomized, placebo-controlled, double-blinded study.

Objective:

To examine the effect of intraoperative epidural administration of Depo-Medrol on postoperative back pain and radiculitis symptoms in patients undergoing Transforaminal Lumbar Interbody Fusion (TLIF).

Summary of Background Data:

Postoperative pain is commonly experienced by patients undergoing spinal fusion surgery. Adequate management of intense pain is necessary to encourage early ambulation, increase patient satisfaction, and limit opioid consumption. Intraoperative steroid application has been shown to improve postoperative pain in patients undergoing lumbar decompression surgeries. There have been no studies examining the effect of epidural steroids on both back pain and radicular pain in patients undergoing TLIF.

Method:

In all, 151 patients underwent TLIF surgery using rh-BMP2 with 3 surgeons at a single institution. Of those, 116 remained in the study and were included in the final analysis. Based on a 1:1 randomization, a collagen sponge saturated with either Saline (1 cc) or Depo-Medrol (40 mg/1 cc) was placed at the annulotomy site on the TLIF level. Follow-up occurred on postoperative days 1, 2, 3, 7, and postoperative months 1, 2, and 3. Lumbar radiculopathy was measured by a modified symptom- and laterality-specific Visual Analog Scale (VAS) regarding the severity of back pain and common radiculopathy symptoms.

Results:

The patients who received Depo-Medrol, compared with those who received saline, experienced significantly less back pain on postoperative days 1, 2, 3, and 7 (P<0.05). There was no significant difference in back pain beyond day 7. Radiculopathy-related symptoms such as leg pain, numbness, tingling, stiffness, and weakness tended to be reduced in the steroid group at most time points.

Conclusion:

This study provides Level 1 evidence that intraoperative application of Depo-Medrol during a TLIF surgery with rh-BMP2 significantly reduces back pain for the first week after TLIF surgery. The use of epidural Depo-Medrol may be a useful adjunct to multimodal analgesia for pain relief in the postoperative period.

Key Words:

lumbar fusion
multimodal pain management
epidural steroid
TLIF
randomized clinical trial
postoperative pain
SDCT
OPEN-ACCESSTRUE
STATUSONLINE-ONLY
==== Body
pmcLumbar fusion surgery is a commonly performed procedure for those experiencing back and leg pain stemming from lumbar disk degenerative disease, spondylolisthesis, and lumbar spinal stenosis1. TLIF (transforaminal lumbar interbody fusion) is a popular technique for the performance of lumbar fusion. The technique involves the removal of a unilateral facet complex and partial replacement of the intervertebral disk with a structural implant and bone graft material. Many surgeons utilize INFUSE (recombinant human bone morphogenetic protein-2 [rh-BMP2]; Medtronic, Memphis, TN) in an off-label manner to promote successful fusion.2–6

Few studies, however, have investigated the use of intraoperative steroid application in the setting of TLIF surgeries. While TLIF with rhBMP-2 has a strong track record of clinical success, many patients suffer from early postoperative back pain and lumbar radiculitis.7–11 Efforts to minimize postoperative pain in recent years have increasingly focused on the concurrent use of analgesics from several complementary classes to minimize pain, reduce total narcotic consumption, and optimize function. Despite significant improvements to patient recovery provided through the use of multimodal analgesia, postoperative pain remains a major challenge to patients recovering from TLIF surgery.

Intraoperative steroid has been used to reduce postoperative pain following lumbar decompression procedures.12–16 Intraoperative epidural steroid application theoretically reduces inflammation arising from the longstanding degenerative pathology and from the surgical intervention itself.17,18 Epidural steroid application also has the potential long-term benefit of reduced scar tissue formation. Studies on the use of intraoperative steroids following lumbar discectomy have identified a significant short-term decrease in postoperative pain.12,19 Haws et al published the only study examining the utility of epidural steroid application with TLIF. The study, however, did not show any reduction in overall pain with steroid application at postoperative day-2 or 6 weeks. Unfortunately, this study did not investigate the level of pain during the interval between day 2 and 6 weeks, nor did it differentiate between back pain and radicular symptoms.20–23

The shortcomings of the Haws study, in combination with the positive results from discectomy studies, provide the basis for the current investigation. Specifically, the effect of epidural steroid application during TLIF using rhBMP-2 on back pain and radiculitis during the early postoperative period is evaluated. During TLIF, a unilateral facet complex is removed, and the annulus is entered on either the left or right side. The nerves on the side of the facetectomy/annulotomy are particularly susceptive to inflammation due to operative manipulation and potentially due to the proximity to rhBMP-2. Accordingly, this study specifically investigated the effect of intraoperative Depo-Medrol application to the site of the facetectomy/annulotomy on the development of back pain and postoperative radiculitis. Our hypothesis is that patients receiving local Depo-Medrol will experience reduced postoperative back pain and radiculitis symptoms after TLIF with rhBMP-2.

METHODS

Study Design

The study is a prospective, randomized, placebo-controlled, double-blinded trial of 116 patients, conducted consecutively between September 2021 and March 2022 by 3 surgeons at a single center. The Institutional Review Board approved the study protocol and informed consent form under IRBnet ID 1766672. Informed consent was obtained from all subjects. The study received no grant, institutional, or industrial support.

Eligible subjects were patients undergoing elective 1-level or 2-level lumbar decompression and instrumented fusion with interbody arthrodesis using a TLIF technique. All patients had preoperative radicular or claudicatory symptoms. Exclusion criteria included known hypersensitivity to medications used in the study. In all, 166 patients were considered for enrollment. Of those, 15 patients were not interested in participating. The study sample included 151 patients who were randomized.

1:1 randomization was achieved through opaque sealed envelopes created before enrollment. An investigator who was not involved in data collection used a random number generator to indicate the Depo-Medrol group and the Saline group.

Power Analysis

A pilot study was conducted to determine the number of patients needed to show significance. Thirty-two patients receiving a 1-level or 2-level TLIF were recruited in this pilot study. Consent was received for each patient. All 32 subjects were locally administered 40 mg of Depo-Medrol during the time of their surgery. The pilot study showed that 6 out of the 32 patients reported postoperative radiating leg pain. Using these values, we determined that 128 patients would need to be enrolled to best show a significant difference between the treatment and control groups in this study (alpha=0.05, 0.9 statistical power). We did not expect a high incidence of dropout and decided to enroll 150 patients to accommodate for dropout.

Surgical Technique

At the time of surgery, the circulating nurse applied either saline or Depo-Medrol in accordance with randomization to a 1 cm*2 cm sterile collagen sponge. Patients underwent TLIF. Following instrumentation, decompression and subtotal discectomy, a PEEK interbody strut filled with local bone graft and 0.6 cc of reconstituted Infuse (0.9 mg) was inserted into the ventral aspect of the intervertebral space. Ten ccs of cancellous allograft were then placed dorsal to the interbody strut within the intervertebral space. After generous epidural and wound irrigation with antibiotic-laden saline, a collagen sponge saturated with either Depo-Medrol 40 mg (1 cc) or normal saline (1 cc) was then placed over the annulotomy site by the surgeon (Fig. 1). Posterolateral fusion was performed bilaterally with local bone graft, cancellous allograft and Infuse (7.4 mg total with 3.7 mg per side) in all patients. Neuromonitoring was not utilized. Before closure, a gram of Cefazolin and a gram of Vancomycin powder were sprinkled over the deep and superficial tissues in all patients. All patients received subcutaneous and intramuscular injections of 30 cc of 0.5% Marcaine during wound closure. Postoperative multimodal pain management included a lumbosacral corset, Tylenol, Toradol, topical ice, muscle relaxer (typically Baclofen), and opiates (Tramodol, Hydrocodone, or Oxycodone). Patients receiving preoperative nerve-modulating medications, Lyrica (Pregabalin) and Gabapentin (Neurontin), were continued on them postoperatively. Nerve-modulating medications were not routinely prescribed postoperatively.

FIGURE 1 Illustrations demonstrating the anatomy pertinent to steroid-saturated collagen sponge placement through a right-sided TLIF at L5-S1.

(A) The inferior facet of L5 and the superior facet of S1 have been removed. An annulotomy was performed, followed by removal of the nucleus pulposus and endplate cartilage. A PEEK implant has been placed within the anterior portion of the intervertebral space. The exiting L5 nerve root is partially exposed cephalad and lateral to the annular defect. The traversing S1 nerve is immediately medial to the annulotomy defect. A combination of local bone graft and cancellous allograft is placed within the intervertebral space to serve as an osteoconductive matrix (not demonstrated). (B) After completion of the interbody graft placement, a collagen sponge 1 cm×2 cm in size is folded and placed partially within the annular defect and partially dorsal to the remaining annulus in contact with the exposed portions of the L5 and S1 nerve roots.

Data Collection

Patient baseline symptoms were documented before the surgery. The Lumbar Radiculopathy Questionnaire (LRQ) (Supplement A, Supplemental Digital Content 1, http://links.lww.com/CLINSPINE/A318) was administered preoperatively and at each follow-up time point. The LRQ is a modified version of the Visual Analog Scale (VAS) created for the purpose of this study that measures the severity of common lumbar radiculopathy symptoms: leg-specific and laterality-specific tingling, numbness, stiffness/cramping, weakness, pain, and a low back specific VAS score. Patient Health Questionnaire (PHQ-9) was also obtained preoperatively. Recorded perioperative variables were procedure time, estimated blood loss, and intraoperative complications.

Questionnaires were completed on postoperative days 1, 2, 3, 7, postoperative months 1, 2, and 3. LRQ was administered over the telephone or during postoperative clinic visits. Additional data collection variables included patient use of nerve-modulating medications such as Lyrica (Pregabalin) and Gabapentin (Neurontin), and additional steroid medications such as Methylprednisolone or Epidural Steroid Injections. Any complications or reoperations during the postoperative period were also recorded. The study coordinator remained blinded to the study group of the patients throughout data collection.

Statistical Analysis

The sample size of 128 patients was estimated to provide 90% power. Statistical analysis was performed using R Studio (Version 3.33; R Studio, Inc. Boston, MA). For each sensation-specific and location-specific VAS scores obtained using the LRQ, t-test was used to analyze the continuous variables. Categorical variables were analyzed using the χ2 test. Data regarding nerve-modulating medication use was analyzed using the Fisher test. Statistical tests were two-sided, and significance was determined by an alpha of 0.05.

RESULTS

A total of 151 patients were enrolled and randomized to the Depo-Medrol group (n=74) and Saline group (n=77). Four patients in the Depo-Medrol group and 6 patients in the Saline group did not receive an interbody arthrodesis based on intraoperative surgeon decision-making. The most common reasons for intraoperative avoidance of interbody arthrodesis were unexpected low bone density and abnormal nerve root anatomy. These 10 patients were excluded from the analysis. Two additional patients were excluded due to a breach in the standard operative protocol. (1 in Depo-Medrol and 1 in Saline). One patient experienced a dural tear during the surgery, and thus, the surgeon decided not to open the randomization envelope (1 Saline). In the other case, the patient (Depo-Medrol) was excluded as the surgeons realized that the nerve pain was originating from a different level of the surgery. Two additional patients were excluded as they received revision decompression surgeries 2 days following the original surgery (2 Saline). One additional patient sustained a fall a month after the original surgery, requiring surgical intervention (1 Saline), and was thus excluded. Twelve patients were lost to follow-up (6 Depo-Medrol, 6 Saline). Two patients withdrew consent postoperatively and did not complete questionnaires.

In total, 116 patients were included in the final analysis, of which 57 (49.1%) and 59 (50.9%) were in the Depo-Medrol and Saline group, respectively (Fig. 2).

FIGURE 2 CONSORT transparent reporting of trials enrollment flow diagram.

The 2 patient groups were similar in terms of patient demographics, number of levels operated on, number of prior lumbar spine surgeries, preoperative PHQ-9 score, and number of cases performed per surgeon. (Table 1). Perioperative characteristics and complication rates are reported in Table 2. Operative time and estimated blood loss (EBL) were similar in the treatment and control groups.

TABLE 1 Summary of Baseline Patient Characteristics in 116 Patients

Demographics	CONTROL, n=57	DEPO-MEDROL, n=59	P *	
Age, y	64.0±12.1	62.5±9.1	0.461	
Gender, n (%)	
 Female	28 (49.1)	31 (47.5)	0.713	
 Male	29 (50.9)	28 (47.5)	—	
Fusion levels	—	—	0.452	
 1-level	41 (71.9)	46 (78.0)	—	
 2-level	16 (28.1)	13 (22.0)	—	
Pre-op Patient Health Questionnaire-9 Score	6.21±5.02	6.85±5.87	0.484	
* P-value was obtained using χ2 test for qualitative variables and t-test for quantitative variables.

TABLE 2 Summary of Operative Characteristics in 116 Patients Who Underwent TLIF Surgery

	CONTROL, n=57	DEPO-MEDROL, n=59	P *	
Complication	
 Urinary retention	2	1	0.538	
 Infection	1	1	0.579	
 Revision decompression	0	1	—	
 Reoperation†	1	2	0.326	
* P-value was obtained using χ2 test for qualitative variables and t-test for quantitative variables.

† 1 patient in the control group and 1 patient in the Depo-Medrol developed a postoperative infection that required surgical intervention (Incision and Drainage surgery). One patient in the Depo-Medrol group underwent revision decompression on postoperative day 1.

The 2 groups were also similar in terms of postoperative complications. Two patients in the control group and 1 patient in the Depo-Medrol group experienced transient postoperative urinary retention. One patient in both groups (2 patients total) developed surgical site infections (SSI) that did not resolve with oral antibiotics and required surgical intervention. One patient in the Depo-Medrol group developed radiculopathy symptoms on the side opposite of where the TLIF was performed and required a revision unilateral decompression on postoperative day 3.

The primary outcome variables measured for this study were back pain and leg radiculitis, measured by the Lumbar Radiculopathy Questionnaire, a modified laterality-specific and symptom-specific Visual Analog Scale (Supplement A, Supplemental Digital Content 1, http://links.lww.com/CLINSPINE/A318). The LRQ contains laterality-specific questions regarding the presence or severity of symptoms (1) tingling, (2) numbness, (3) weakness/loss of strength, (4) stiffness/cramping, (5) pain in the legs, feet, or toes, and (6) pain in the low back region. No significant difference in all 6 questions was observed in the treatment and control group preoperatively (Figs. 3–8).

FIGURE 3 Mean low back pain VAS Score over time. Error bars represent 95% confidence intervals.

FIGURE 4 Mean tingling VAS score over time. Error bars represent 95% confidence intervals.

FIGURE 5 Mean numbness VAS score over time. Error bars represent 95% confidence intervals.

FIGURE 6 Mean weakness VAS score over time. Error bars represent 95% confidence intervals.

FIGURE 7 Mean stiffness/cramping VAS score over time.

FIGURE 8 Mean leg pain VAS score over time. Error bars represent 95% confidence intervals.

Patients in the steroid group reported significantly lower back pain as measured by VAS pain score throughout postoperative day 1 (POD1) (3.81 vs. 5.14, P=0.013), POD2 (4.31 vs. 5.66, P=0.006), POD3 (3.68 vs. 5.44, P=0.001), and POD7 (3.53 vs. 4.79, P=0.015) (Table 3). The lower mean back pain VAS score persisted throughout postoperative month (POM) 1, 2, and 3 (Fig. 3).

TABLE 3 Summary of Mean Low Back Pain VAS Score Over Time

Study group	Pre-Op	POD 1	POD 2	POD 3	POD 7	POM 1	POM 2	POM 3	
Control mean±SD	5.97±2.6	5.14±2.94	5.66±2.56	5.44±2.74	4.79±2.7	3.42±2.06	2.69±2.3	2.83±2.26	
Steroid mean±SD	5.73±2.77	3.81±2.64	4.31±2.64	3.68±2.8	3.53±2.76	2.85±2.25	2.5±2.45	2.76±2.57	
P	0.638	0.013**	0.006***	0.001***	0.015**	0.158	0.662	0.866	
P-value was obtained using χ2 test for qualitative variables and t-test for quantitative variables.

** Statistically significant at P < 0.05.

*** Statistically significant at P < 0.01.

The following 6 figures illustrate the mean VAS score denoting the severity of the 5 radiating symptoms: tingling, numbness, weakness, stiffness/cramping, and leg pain (Figs. 3–7) (Table 4). Radicular symptoms tend to be less severe in the steroid group for most of the postoperative period. The severity of the numbness was significantly lower in the steroid group at POM2.

TABLE 4 Summary of Mean Tingling VAS Score Over Time

Study group	Pre-Op	POD 1	POD 2	POD 3	POD 7	POM 1	POM 2	POM 3	
Control mean±SD	3.16±2.97	0.84±1.96	0.78±1.89	0.84±2.09	0.81±1.76	2.11±2.94	1.79±2.53	1.76±2.68	
Steroid mean±SD	2.9±2.84	0.46±1.54	0.53±1.49	0.44±1.51	1.02±1.85	1.63±2.62	1.26±2.52	1.64±2.65	
P	0.637	0.247	0.432	0.241	0.537	0.361	0.271	0.804	
P-value was obtained using χ2 test for qualitative variables and t-test for quantitative variables.

Twenty-four patients (42.1%) in the saline group and 24 patients (40.7%) in the Depo-Medrol group reported use of nerve-modulating medication such as Gabapentin (Neurontin) and Lyrica (Pregabalin) in the postoperative period (P=0.8072). One patient reported the use of methylprednisolone for knee pain during the follow-up period. No other patients reported use of methylprednisolone or epidural steroid injections within the follow-up period for this study.

Patients with preoperative radicular complaints were analyzed as a separate subgroup. Patients with purely claudicatory symptoms were not included in this subgroup. Subgroup analysis revealed that patients with radicular symptoms preoperatively experienced a more significant benefit with steroid administration. The greatest differences were observed with numbness and weakness (Figs. 9, 10). At postoperative time points 2 months and 3 months, the difference in mean numbness was statistically significant (mean score 0.66 vs. 1.73 POM2; 0.97 vs. 2.13 POM3) (Table 5) (Fig. 9). For patients reporting some degree of preoperative weakness, the steroid group reported significantly greater improvement in their radicular weakness symptoms 2 months postoperatively (mean score 1.12 vs. 2.34 POM2) Table 6) (Fig. 10).

FIGURE 9 Mean numbness VAS Score is represented over the postoperative period for patients who noted a numbness VAS score greater than 0 preoperatively. Error bars represent 95% confidence intervals.

FIGURE 10 Mean Weakness VAS Score is represented over the postoperative period for patients who noted a numbness VAS score greater than 0 preoperatively. Error bars represent 95% Confidence Intervals.

TABLE 5 Summary of Mean Numbness VAS Over Time with Preoperative Score >0

Study group	Pre-Op	POD 1	POD 2	POD 3	POD 7	POM 1	POM 2	POM 3	
Control mean	4.76	1.45	1.29	1.24	1.20	1.88	1.73	2.13	
Steroid mean	4.50	1.33	0.44	0.56	1.00	2.14	0.66	0.97	
P	0.643	0.840	0.101	0.158	0.689	0.655	0.048**	0.040**	
P-value was obtained using χ2 test for qualitative variables and t-test for quantitative variables.

** Statistically significant at P <0.05.

TABLE 6 Summary of Mean Weakness VAS Over Time with Preoperative Score >0

Study group	Pre-Op	POD 1	POD 2	POD 3	POD 7	POM 1	POM 2	POM 3	
Control mean	4.81	1.54	1.89	1.54	1.11	1.47	2.34	2.34	
Steroid mean	4.14	1.14	1.00	0.95	0.93	1.21	1.12	1.54	
P-value	0.194	0.473	0.133	0.252	0.705	0.538	0.021**	0.185	
P-value was obtained using χ2 test for qualitative variables and t-test for quantitative variables.

** Statistically significant at P <0.05.

DISCUSSION

This randomized, double-blind, placebo-controlled trial investigated the effect of local application of Depo-Medrol in 116 patients undergoing TLIF surgeries by three surgeons at a single center. The present study findings show statistically strong evidence that the local application of Depo-Medrol decreased postoperative lower back pain. This significant difference was maintained throughout POD1, POD2, POD3, and POD7. In addition, a subgroup analysis of patients who had preoperative radiating leg pain demonstrated leg pain to be statistically lower in the Depo-Medrol group on POD7. While differences between the cohorts in terms of postoperative tingling, numbness, weakness, stiffness/cramping, and leg pain reached statistical significance at only a few time points, the consistent trend was for the steroid group to fare better in each of these domains. These results suggest that local application of Depo-Medrol may provide significant symptom relief related to lower back pain in the postoperative period up to 1 month, as well as a trend toward radicular symptom relief, including tingling, numbness, weakness, stiffness/cramping, and leg pain up to 3 months, particularly in patients with preoperative symptoms. There was no difference in rates of perioperative or postoperative complications.

Postoperative pain control is crucial for promoting a smooth postoperative course, allowing early ambulation, reducing complications, and increasing patient satisfaction. Typical postoperative pain control regimens include the use of opioids. Opioid use is associated with many side effects, such as delirium, constipation, respiratory depression, and physical dependence.

Multimodal pain management seeks to optimize pain while minimizing opioid consumption. Recommended multimodal agents include tylenol, NSAIDs, neuromodulatory medications, local anesthetic infiltration, ice, and a lumbosacral corset. Intraoperative epidural application of Depo-Medrol is an appealing addition to the multimodal postoperative pain management armamentarium.

Previous studies found an association between intraoperative corticosteroid application and postoperative infection. Lowell et al observed three cases of epidural abscess out of 31 patients undergoing lumbar microdiscectomy with intraoperative epidural methylprednisolone. Kramer et al reported that a significantly high rate of surgical site complications requiring surgical debridement correlated with the perioperative morphine nerve paste use after laminectomy in a retrospective study. Morphine nerve paste was applied directly to the dura and consisted of 4 components: 80 mg Depo-Medrol, aminocaproic acid, morphine sulfate, and microfibrillar collagen hemostat. In the current study, however, there were no observable differences in infection rate in the Depo-Medrol group compared with the control group. One patient in the control group and 1 in the steroid group developed an infection requiring surgical debridement.

The high rates of complications reported in past studies could be attributed to the different locations and different amounts of steroids used. Lowell et al administered the Depo-Medrol directly onto the midline epidural space. The morphine nerve paste from the Kramer et al study contained double the dose of Depo-Medrol compared with the current study. In the current study, 1 ml (40 mg) of Depo-Medrol was applied at the annulotomy site. It is unknown whether the location of steroid application, the dose of steroid used, or the concurrent application of Ancef and Vancomycin to tissues before closure may have influenced the reduced incidence of infection in the current study relative to prior published studies.

A few reports in the literature suggest that epidural application of steroids during lumbar decompression surgery may be associated with a late development of CSF leak.24,25 A systematic review of epidural steroid application during lumbar decompression surgery by Jamjoom et al concluded that epidural steroid application was not associated with an increased risk of postoperative complications. No cases of delayed CSF leak were encountered in the current study.

The current study has several limitations. First, there were a total of 17 patients who were excluded from the analysis after being enrolled and randomized. Due to a higher level of exclusions, the a priori sample size of 128 determined from the pilot study and subsequent power analysis was not met. Had the sample size been larger, it is fair to speculate whether the consistent trend toward reduced radicular symptoms in the steroid group might have reached consistent statistical significance.

Second, the exact duration of the local steroid effect is difficult to determine from the present study. While there were 4 measures obtained between POD0 and POM1, more frequent and equally distributed measurements might help determine the duration of efficacy. Further, there is a subjective element to the patient-reported outcome of the severity of symptoms. While the questions were read verbatim to all patients by a blinded researcher, it is conceivable that telephone administration of the survey could have biased the blinded patient’s response.

Finally, it can be hypothesized that local Depo-Medrol could have an adverse effect on bone healing and thus put patients at an increased risk for nonunion. The study follow-up interval is too short to make any assessment in this regard. Accordingly, the long-term effects of epidural steroid application during TLIF should be considered an attractive topic for evaluation in future studies.

rhBMP-2 was utilized in each of the cases within this series, which is consistent with the authors’ practice pattern. Whether the results of this study are applicable to TLIF surgery performed in the absence of rhBMP-2 is unknown. Such is an appealing topic for future investigation.

Offsetting these limitations are many unique strengths of the study. The randomized, prospective, blinded, and controlled study design provides Level 1 evidence supporting the beneficial role of epidural Depo-Medrol in reducing back pain after TLIF. Further, this study identifies a very appealing new agent to add to the postoperative multimodal analgesic armamentarium. Finally, this study opens several new opportunities for investigation, including the role of epidural steroids in reducing radicular symptoms, optimal steroid dosing, the effect on postoperative narcotic consumption, and the potential benefit to patients undergoing TLIF procedures without Infuse.

Epidural application of Depo-Medrol can be expected to optimize the local anti-inflammatory effect while minimizing the undesirable systemic effects associated with IV or oral steroid administration. Depo-Medrol was selected for use relative to other steroid preparations for several reasons. The carrier combined with methylprednisolone in Depo-Medrol provides for a longer duration of steroid effect (3–6 mo)26 relative to other commonly used epidural steroids. Depo-Medrol is cost-effective ($10.57/vial at our institution) and readily available. Finally, surgeons have a comfort level with Depo-Medrol due to its broad utilization with pain management and orthopedic injections.

CONCLUSION

In conclusion, this randomized, double-blinded, placebo-controlled study provides Level 1 evidence that intraoperative epidural application of Depo-Medrol during 1 to 2-level lumbar TLIF surgery significantly reduces back pain within 1 month and appears to have a beneficial effect on a spectrum of radicular symptoms.

H.S.: Conception and design, administrative support, collection and assembly of data, data analysis and interpretation, manuscript writing, and final approval of manuscript. C.E.: Conception and design, provision of study materials or patients, and final approval of manuscript. R.C.: Conception and design, manuscript writing, final approval of manuscript; A.P.: administrative support, manuscript writing, and final approval of manuscript; C.C.: Collection and assembly of data, manuscript writing, and final approval of manuscript; A.S.: Conception and design, provision of study materials or patients, manuscript writing, and final approval of manuscript; J.P.: Conception and design, provision of study materials or patients, manuscript writing, and final approval of manuscript.

The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). The study was approved by The Institutional Review Board (IRBnet ID 1766672), and informed consent was obtained from all individual participants. All authors have completed the ICMJE uniform disclosure form.

The authors declare no conflict of interest.

Supplemental Digital Content is available for this article. Direct URL citations are provided in the HTML and PDF versions of this article on the journal’s website, www.jspinaldisorders.com.
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