Postoperative pain management is one of the milestones of fast-track or enhanced recovery after surgery clinical pathways, which has received growing attention in recent years, especially for spinal procedures.1 Significant pain in the early postoperative course is a common finding among patients undergoing lumbar spine surgery.2 In addition to delayed mobilization and a resultant prolonged hospital stay, poorly controlled postoperative pain could result in cardiovascular, pulmonary, and cerebrovascular complications as well as an increased risk of chronic pain.3–7 Therefore, effective strategies to reduce postoperative pain in lumbar spinal procedures are in high demand.
Various strategies for postoperative pain management in lumbar spine surgery have been implemented, one of which is the use of epidural steroids.3,4 Prior studies have demonstrated significant improvements in postoperative visual analog scale (VAS) scores (both back and leg), reductions in length of hospital stay (LOS), and postoperative cumulative morphine consumption following the use of epidural steroids in patients undergoing lumbar discectomy and laminectomy.8–15 The observed effects are possibly attributable to the antiinflammatory properties of corticosteroids that prevent the subsequent fibrosis and resultant chronic pain.16 Although this modality has been widely investigated in lumbar discectomy, currently there is scarce information regarding its efficacy in lumbar spinal fusion surgery.
Hence, due to the paucity of data, the present randomized, double-blind, controlled trial was designed to evaluate the efficacy of intraoperative local administration of corticosteroids in postoperative pain management and patient-reported outcomes in patients undergoing posterolateral lumbar spinal fusion surgery.
Methods
Trial Design
This study was a randomized, double-blind, placebo-controlled, parallel-group trial approved by the institutional review board of the Shohada Tajrish Hospital and the ethics committee of Shahid Beheshti University of Medical Sciences. This study was registered with the Iranian Registry of Clinical Trials database (https://www.irct.ir/), and its registration no. is IRCT20200502047277N6. All patients undergoing elective, instrumented posterior lumbar spinal fusion surgery between July 2020 and July 2021 were assessed for eligibility. Written informed consent was obtained from all participants following the recruitment process. In order to improve the reporting of results, this trial was conducted in accordance with the Consolidated Standards for Reporting of Trials (CONSORT) guidelines.
Inclusion criteria were age > 18 years, degenerative indications (e.g., spondylolisthesis, spinal stenosis, disc herniation, or spondylosis) for elective posterior instrumented lumbar spinal fusion surgery, and written informed consent. Patients who were scheduled to undergo posterior lumbar spinal fusion for nondegenerative pathologies (e.g., tumor, trauma, deformity, or infection); had a prior history of hypersensitivity or anaphylactic reaction to the study drug; had previously undergone lumbar spinal fusion surgery; or had severe concurrent comorbidity (defined as American Society of Anesthesiologists [ASA] physical status > II) or psychiatric disorder were excluded from the study.
Patients were randomly assigned (a 1:1 ratio) to one of two groups (treatment or control) via computer-generated block randomization performed using SPSS version 24 (IBM Corp.) on the day of surgery, before the operation. The person who performed the preoperative randomization was not part of the study. Sealed opaque envelopes were used for allocation concealment. One surgeon who was not blind to the patients’ allocation and study intervention in each group performed all the operations in the study. The surgeon, however, did not take part in the data collection and investigation processes after the operation. Patients, the principal investigator, outcome assessors, and data analyzers were merely informed of the study group number (1 or 2) and remained blind to the intervention performed in each study group throughout the course of the study.
Interventions
All patients in this study underwent posterolateral lumbar spinal fusion surgery performed by the same surgeon and surgical team. Following the intubation, patients were placed in the prone position, and one midline incision was made, the length of which was adjusted according to the number of levels of fusion anticipated preoperatively. After the complete bony dissection, nerve roots were decompressed in a posterolateral fashion. Depending on each case, multilevel laminectomy, facetectomy, foraminotomy, and discectomy were also performed; however, no patient in this study underwent posterior lumbar interbody fusion. Next, the conventional method of pedicle screw-rod instrumentation was used, and harvested autologous bone grafts mixed with allograft bone chips were placed bilaterally on the transverse processes and laminae. In the treatment group, a Gelfoam carrier soaked in 1 ml of triamcinolone acetonide (40 mg) for 5 minutes was placed over the nerve roots at the epidural space before the closure. The size of the Gelfoam was adjusted based on the epidural space, and for each pair of nerve roots, 1 ml of triamcinolone acetonide was used. The same was performed for patients in the control group, except that this was done via a Gelfoam carrier soaked in 1 ml of normal saline. The drain was fixed, and the wound closure was performed in a layered fashion.
For anesthesia and perioperative pain management, the same process was applied to both study groups. Thirty minutes before the end of the surgery, paracetamol 1 g, ondansetron 4 mg, and morphine 0.1 mg/kg were administered. All patients were also instructed preoperatively how to use the patient-controlled analgesia device, which was attached to them at the end of surgery. The patient-controlled analgesia device was set to deliver morphine 20 µg/kg and ondansetron 12 mg (in 150 ml of normal saline) at a basal rate of 2 ml/hr and 1 ml per patient’s demand (10-minute lockout period). Meperidine 50 mg and ondansetron 4 mg were used as additional analgesia and antiemetic agents, respectively, at the patient’s request.
Outcome Measures
Patients were assessed at the following time points: at baseline; at 2, 4, 6, 12, 24, and 48 hours postoperatively; and at 4 and 12 weeks after the surgery to evaluate the study outcome measures. The primary outcome measure of the study was postoperative leg pain based on the 10-cm VAS score (0 = no pain, 10 = worst imaginable pain) for leg pain both at rest and with movement during the first postoperative day at 2, 4, 6, 12, 24, and 48 hours postoperatively. Secondary outcome measures of the present study included VAS scores for leg and back pain at 4 and 12 weeks postoperatively, cumulative postoperative 24-hour morphine consumption, Oswestry Disability Index (ODI), LOS, postoperative nausea and vomiting (PONV), and the incidence of postoperative complications. Moreover, demographic, clinical, and surgical characteristics were recorded. Patient-reported outcomes, including VAS scores (in addition to acute postoperative values) for back and leg pain, along with ODI, were recorded at 4 and 12 weeks postoperatively.
Statistical Analysis
A number of previous studies have demonstrated the efficacy of epidural steroids in reducing pain after a lumbar discectomy.14 Therefore, according to their findings, by assuming a mean VAS score of 3.2 for the control group at 24 hours postoperatively and an SD of 1.7, a minimum of 94 patients (47 in each arm) would be required to observe a change of 1 point in the mean VAS score with a power of 0.80 and a 2-sided significance level of 0.05. After anticipating a dropout rate of 6%, a total of 100 (50 in each arm) was estimated for this study.
Data were analyzed using an intention-to-treat approach. Quantitative data were expressed as the mean ± SD, and qualitative data were presented as frequency and percentage in the present study. The Mann-Whitney U-test was used to compare the continuous data between the two groups (treatment and control) at each time point. Moreover, the changes in postoperative outcome measures (postoperative value − baseline value) were also compared between the two groups using the Mann-Whitney U-test. A backward stepwise multiple linear regression analysis was performed to assess the differences in changes in patient-reported outcome measures (VAS, ODI, and cumulative morphine consumption as the response variable) between the two groups while adjusting for sex, the number of fused levels, and preoperative pain. Similarly, Poisson regression was also carried out to evaluate the impact of study intervention on the percentage of patients who reached the minimum clinically important difference (MCID) while controlling for the aforementioned confounders. The incidence rate ratio (IRR) of the study groups was also estimated by performing the Poisson regression. The goodness of fit of the Poisson regression model was checked using the chi-square goodness-of-fit test. In order to compare the categorical data between the two groups, either the chi-square or Fisher’s exact test was used. Probability values less than 0.05 were considered statistically significant. All statistical analyses in this study were performed using SPSS version 24. Poisson regression was performed using Stata version 15 (StataCorp).
Results
Patient Characteristics
Between July 2020 and July 2021, a total of 168 patients were screened for eligibility. Among them, 52 patients did not meet the study criteria and 16 refused to participate. Thus, a total of 100 patients were recruited in this study and randomly allocated to receive either intraoperative local epidural corticosteroid or placebo. All patients in both study groups received their assigned intervention, and no dropouts occurred during the study period (Fig. 1).
Data on participants in study, prepared using the CONSORT 2010 Flow Diagram template (available at http://www.consort-statement.org/). Figure is available in color online only.
Regarding the patients’ baseline characteristics, no significant difference was found (p > 0.05) between the two groups in age, sex, BMI, smoking status, comorbidities, preoperative indications for surgery, ASA physical status, VAS scores (for both back and leg pain), and ODI. Surgical information, including the number of levels of fusion, duration of operation, and estimated intraoperative blood loss, was also similar (p > 0.05) in both study groups. Table 1 demonstrates the differences in demographic, clinical, and surgical characteristics of the two study groups (treatment and control).
Demographic, clinical, and surgical characteristics of 100 patients who underwent spinal fusion
| Characteristic | Treatment, n = 50 | Control, n = 50 | p Value |
|---|---|---|---|
| Age in yrs, mean (SD) | 51.7 (11.7) | 48.5 (12.5) | 0.189 |
| Sex, no. (%) | 0.405 | ||
| Male | 16 (32.0%) | 20 (40.0%) | |
| Female | 34 (68.0%) | 30 (60.0%) | |
| BMI, mean (SD) | 28.1 (4.8) | 28.7 (4.1) | 0.550 |
| Smoking status, no. (%) | 0.298 | ||
| Smoker | 7 (14.0%) | 11 (22.0%) | |
| Nonsmoker | 43 (86.0%) | 39 (78.0%) | |
| Comorbidities, no. (%) | |||
| Diabetes mellitus | 3 (6.0%) | 5 (10.0%) | 0.715 |
| Hypertension | 9 (18.0%) | 13 (26.0%) | 0.334 |
| Pulmonary disease | 0 (0.0%) | 1 (2.0%) | 1.00 |
| Prior lumbar decompression, no. (%) | 4 (8.0%) | 6 (12.0%) | 0.505 |
| Diagnosis, no. (%) | |||
| Spondylolisthesis | 38 (76.0%) | 33 (66.0%) | 0.271 |
| Spinal stenosis | 44 (88.0%) | 42 (84.0%) | 0.564 |
| Disc herniation | 7 (14.0%) | 5 (10.0%) | 0.538 |
| Spondylosis | 18 (36.0%) | 15 (30.0%) | 0.523 |
| ASA class, no. (%) | 0.230 | ||
| I | 29 (58.0%) | 23 (46.0%) | |
| II | 21 (42.0%) | 27 (54.0%) | |
| Baseline scores, mean (SD) | |||
| VAS for back pain | 5.7 (1.6) | 5.8 (1.7) | 0.594 |
| VAS for leg pain | 6.2 (1.7) | 6.3 (1.8) | 0.734 |
| ODI | 35.4 (9.7) | 36.8 (10.6) | 0.367 |
| No. of levels of fusion, mean (SD) | 3.9 (1.2) | 3.7 (1.0) | 0.565 |
| Duration of surgery in mins, mean (SD) | 243.6 (37.1) | 234.9 (35.6) | 0.206 |
| Estimated blood loss in ml, mean (SD) | 525.7 (270.6) | 572.0 (279.0) | 0.381 |
Primary Outcome Measure
Table 2 shows changes in the value of the VAS score during the first and second postoperative days. There was no significant difference between the two groups in VAS scores for leg pain both at rest (treatment: 5.3 ± 1.6 vs control: 5.1 ± 1.6, p = 0.407) and with movement (treatment: 6.4 ± 1.2 vs control: 6.2 ± 1.1, p = 0.393) at 24 hours postoperatively (Fig. 2). Similarly, the two groups were comparable (p > 0.05) in terms of VAS scores for leg pain both at rest and with movement at 2, 4, 6, 12, and 48 hours postoperatively (Fig. 2). No significant difference in changes in VAS score for leg pain both at rest (treatment: −0.9 ± 2.3 vs control: −1.3 ± 2.5, p = 0.487) and with movement (treatment: 0.2 ± 1.9 vs control: −0.1 ± 2.2, p = 0.497) was found. Changes in VAS scores for leg pain both at rest and with movement at each time point are depicted in Table 2. Similar to univariate analyses, multiple linear regression controlled for sex, preoperative VAS score for leg pain, and the number of fused levels found no significant difference between the study groups and changes in the VAS score of leg pain both at rest (B = 0.035 and p = 0.588) and with movement (B = 0.048 and p = 0.401) at 24 hours postoperatively.
Primary and secondary outcome measures in 100 patients who underwent spinal fusion
| Outcome | Treatment | Control | p Value | |||
|---|---|---|---|---|---|---|
| Mean Value | Changes | Mean Value | Changes | Mean Value | Changes | |
| VAS score for leg pain at rest | ||||||
| 2 hrs | 6.5 (1.8) | 0.3 (2.3) | 6.1 (1.8) | −0.2 (2.5) | 0.257 | 0.238 |
| 4 hrs | 5.4 (1.8) | −0.9 (2.2) | 5.2 (1.6) | −1.2 (2.3) | 0.526 | 0.549 |
| 6 hrs | 5.3 (1.5) | −0.9 (2.0) | 5.0 (1.4) | −1.4 (2.2) | 0.241 | 0.439 |
| 12 hrs | 4.6 (1.0) | −1.7 (1.7) | 4.4 (1.0) | −1.9 (2.0) | 0.310 | 0.458 |
| 24 hrs | 5.3 (1.6) | −0.9 (2.3) | 5.1 (1.6) | −1.3 (2.5) | 0.407 | 0.487 |
| 48 hrs | 4.0 (1.3) | −2.2 (2.3) | 3.8 (1.1) | −2.5 (2.3) | 0.520 | 0.710 |
| VAS score for leg pain w/ movement | ||||||
| 2 hrs | 7.7 (1.8) | 1.4 (2.3) | 7.6 (1.6) | 1.2 (2.4) | 0.732 | 0.658 |
| 4 hrs | 6.8 (1.5) | 0.5 (2.2) | 6.6 (1.4) | 0.3 (2.3) | 0.490 | 0.531 |
| 6 hrs | 6.3 (1.4) | 0.1 (2.1) | 6.2 (1.1) | −0.2 (2.3) | 0.380 | 0.554 |
| 12 hrs | 5.4 (1.1) | −0.8 (1.9) | 5.3 (1.0) | −1.1 (2.1) | 0.246 | 0.503 |
| 24 hrs | 6.4 (1.2) | 0.2 (1.9) | 6.2 (1.1) | −0.1 (2.2) | 0.393 | 0.497 |
| 48 hrs | 5.2 (0.9) | −1.0 (1.9) | 4.9 (0.9) | −1.5 (2.0) | 0.111 | 0.329 |
| Cumulative 24-hr morphine consumption, mg | 38.3 (12.2) | NA | 38.7 (11.2) | NA | 0.839 | NA |
| LOS, hrs | 136.0 (37.3) | NA | 137.0 (31.1) | NA | 0.953 | NA |
| PONV, no. (%) | 13 (26.0%) | NA | 18 (36.0%) | NA | 0.280 | NA |
NA = not applicable.
Unless otherwise indicated, values are expressed as the mean (SD). Changes = postoperative value at each time point – preoperative value.
Bar graphs showing the mean postoperative pain scores based on a 10-cm VAS for leg pain both at rest (upper) and with movement (lower) at 2, 4, 6, 12, 24, and 48 hours after the surgery.
Secondary Outcome Measures
No significant difference was observed between the two groups in the cumulative morphine consumption at 24 hours postoperatively (treatment: 38.3 ± 12.2 mg vs control: 38.7 ± 11.2 mg, p = 0.839). Multiple linear regression (adjusted for sex, preoperative pain, and the number of fused levels) found no significant difference in cumulative morphine consumption at 24 hours postoperatively (B = −0.17 and p = 0.865) between the two groups. Likewise, LOS was similar in both groups (treatment: 136.0 ± 37.3 vs control: 137.0 ± 31.1, p = 0.953). In regard to the incidence of morphine-related side effects during the first 72 hours after the surgery, 13 (26.0%) and 18 (36.0%) patients experienced PONV in the treatment and control groups, respectively, but this was not statistically significant (p = 0.280).
Changes in the VAS scores for back and leg pain as well as ODI were also assessed at 4 and 12 weeks postoperatively in this study. No statistically significant difference (p > 0.05) was found between the treatment and control groups regarding the changes in VAS scores for both leg and back pain as well as changes in ODI scores at 4 and 12 weeks after the surgery. At each time point, postoperative values of the aforementioned variables were also comparable (p > 0.05) between the study groups. Table 3 illustrates the changes in VAS (for both leg and back pain) and ODI scores at 4 and 12 weeks postoperatively. Multiple linear regressions adjusted for sex, baseline value of outcome measure, and the number of fused levels also found no significant difference between the two groups in VAS for leg pain (B = −0.019 and p = 0.714), VAS for back pain (B = −0.014 and p = 0.746), and ODI score (B = −0.158 and p = 0.117) at 12 weeks postoperatively.
Mean values with changes in postoperative patient-reported outcomes in 100 patients who underwent spinal fusion
| Outcome | Treatment | Control | p Value | |||
|---|---|---|---|---|---|---|
| Mean Value | Changes | Mean Value | Changes | Mean Value | Changes | |
| VAS score for back pain | ||||||
| Preop | 5.7 (1.6) | NA | 5.8 (1.7) | NA | 0.594 | NA |
| 4 wks | 3.6 (1.1) | −2.1 (1.3) | 3.8 (0.9) | −2.0 (1.6) | 0.281 | 0.877 |
| 12 wks | 2.9 (0.8) | −2.7 (1.6) | 2.9 (0.7) | −2.9 (1.8) | 0.673 | 0.650 |
| VAS score for leg pain | ||||||
| Preop | 6.2 (1.7) | NA | 6.3 (1.8) | NA | 0.734 | NA |
| 4 wks | 4.2 (1.2) | −2.1 (1.3) | 4.4 (0.9) | −1.9 (1.7) | 0.243 | 0.772 |
| 12 wks | 3.4 (1.0) | −2.8 (1.8) | 3.5 (0.9) | −2.8 (1.8) | 0.639 | 0.748 |
| ODI | ||||||
| Preop | 35.4 (9.7) | NA | 36.8 (10.6) | NA | 0.367 | NA |
| 4 wks | 25.1 (8.7) | −10.3 (5.8) | 26.1 (8.7) | −10.7 (4.1) | 0.648 | 0.208 |
| 12 wks | 20.7 (6.9) | −14.7 (6.7) | 23.9 (6.6) | −12.9 (4.7) | 0.033* | 0.384 |
Values are expressed as the mean (SD). Changes = postoperative value at each time point – preoperative value.
Indicates statistically significant at p < 0.05.
With respect to postoperative complications, 4 (8.0%) and 2 (4.0%) patients in the treatment and control groups, respectively, developed superficial surgical site infections (SSIs). However, this difference was not statistically significant (p = 0.678). No significant difference in the percentage of patients who achieved MCID for ODI (treatment: 26 (52.0%) vs control: 31 (62.0%), p = 0.313) and VAS scores for both leg pain (treatment: 38 (76.0%) vs control: 39 (78.0%), p = 0.812) and back pain (treatment: 37 (74.0%) vs control: 38 (76.0%), p = 0.817) was found at 3 months postoperatively. Similarly to univariate analysis, Poisson regression (adjusted for sex, baseline value of outcome measure, and the number of fused levels) found no significant difference in the percentage of patients who achieved MCID for ODI (IRR 0.99 [95% CI 0.58–1.69], p = 0.977) and VAS scores for both back pain (IRR 1.02 [95% CI 0.65–1.62], p = 0.939) and leg pain (IRR 1.02 [95% CI 0.65–1.59], p = 0.923) at 12 weeks postoperatively.
Discussion
According to the results of the present randomized, placebo-controlled trial, intraoperative epidural corticosteroid application did not affect the early postoperative pain significantly in patients who underwent elective posterolateral spinal fusion surgery. Furthermore, postoperative opioid requirements remained unchanged in the group that received epidural steroid in comparison with the control group. Similarly, no significant change was observed in the LOS and postoperative patient-reported outcomes following the administration of epidural corticosteroid in the present study. Moreover, intraoperative epidural use of corticosteroid was not significantly associated with a higher complication rate compared with the placebo. Hence, the findings of the present study do not support the routine use of intraoperative epidural corticosteroids in posterolateral lumbar spinal fusion for better postoperative pain control or improved outcome.
The majority of previous studies have suggested a significant efficacy for epidural use of steroids in reducing postoperative pain, opioid requirement, and LOS in lumbar discectomy procedures.9–14,17,18 In contrast, the present investigation did not demonstrate such a significant impact in posterolateral spinal fusion surgery. According to the most recent systematic review and meta-analysis (level of evidence I), including 12 studies (n = 1006) with either conventional or minimally invasive surgery (MIS) discectomy, application of epidural steroids significantly reduces VAS scores (for both leg and back pain) at 1 week and 1 month postoperatively, as well as reducing morphine consumption and LOS compared with the placebo in patients undergoing lumbar discectomy.14 The subgroup analysis, however, showed that only the conventional discectomy is associated with this significant effect in comparison with the MIS discectomy.
Regarding the method of delivery, most prior studies have used the instillation of the steroid over the epidural space. However, many prior investigations have supported the hypothesis that the use of Gelfoam as a carrier for extended-release epidural administration of various analgesic drugs, such as morphine, buprenorphine, steroids, and levobupivacaine, in lumbar discectomy or laminectomy could prolong the analgesic effect.19–23 Regarding the epidural use of steroids in a sustained-release fashion, although no study has compared it with the instillation method, a number of studies have demonstrated its efficacy in postoperative analgesia. Kumari et al. showed a significant reduction in postoperative tramadol consumption and pain in patients who received Gelfoam soaked in dexamethasone and levobupivacaine compared with those who received Gelfoam soaked in levobupivacaine alone or the control group (normal saline) after lumbar laminectomy.23 Chadduck et al. also found that epidural administration of a piece of autogenous fat soaked in methylprednisolone was associated with significant improvement in postoperative pain following lumbar decompression surgery.19 In addition, a major drawback of drug instillation into the epidural space in comparison with using the Gelfoam carrier is that most of the drug might be lost in the disc space or diluted by tissue fluids or blood. Nevertheless, no study has evaluated the differences in postoperative outcomes between the use of Gelfoam soaked in corticosteroids and instillation of these agents over the epidural space in spinal fusion surgery, and future clinical trials are warranted to assess this topic.
Nevertheless, much of the literature consists of reports on the efficacy of epidural steroids in lumbar discectomy, whereas only a limited number of studies have been devoted to this potential effect in lumbar spinal fusion.12,24 In a prior randomized, double-blind, placebo-controlled trial, Jirarattanaphochai et al. assessed the effects of epidural coadministration of methylprednisolone and bupivacaine on postoperative pain and morphine consumption in patients undergoing lumbar discectomy, decompressive laminectomy, and instrumented lumbar spinal fusion.12 Although their subgroup analysis showed a significant reduction in the postoperative morphine consumption of patients who underwent lumbar discectomy, no such effect was observed for the laminectomy or fusion groups. The findings of this study regarding fusion, however, are limited due mainly to two reasons. First, despite a large study sample size, there is heterogeneity in the type of procedure among the patients, and only 31 patients underwent spinal fusion, with 16 of them in the treatment group. Second, patients in the treatment group received a combination of bupivacaine and methylprednisolone, which might not fully demonstrate the effects of the steroid application given the analgesic effects of local bupivacaine itself.
The present study showed that intraoperative epidural steroid administration does not affect the postoperative pain or patient-reported outcomes in posterolateral spinal fusion. Similar to our findings, Haws et al. found no significant change in postoperative pain, LOS, cumulative morphine consumption, and patient-reported outcomes in patients who received a Gelfoam carrier soaked in 1 ml of methylprednisolone during the MIS transforaminal lumbar interbody fusion compared with the placebo.24 Despite using the MIS approach, this study has been the only clinical trial that assessed the impact of epidural use of steroids on patient outcomes in spinal fusion. Concerning the lumbar discectomy, however, the results have been different. When considering various surgical approaches, conventional discectomy has been significantly effective in improving postoperative patient outcomes.9–12,14,17,18 However, the MIS approach did not lead to the same results in lumbar discectomy.8,14,15,25 Nonetheless, given that there is currently a paucity of data regarding the use of epidural steroids in both conventional and MIS lumbar fusion surgery, further high-quality studies are required.
Changes in patient-reported outcomes, including VAS (for both leg and back pain) and ODI, were not significantly different between the treatment and control groups over 4 and 12 weeks postoperatively in the current study. Likewise, Haws et al. found no significant difference in changes in the aforementioned patient-reported outcomes during 6, 12, and 24 weeks postoperatively.24 By contrast, in the meta-analysis performed by Arirachakaran et al., significant improvements in back and leg VAS scores at 1 and 4 weeks postoperatively were found in patients who underwent lumbar discectomy and received epidural steroids compared with the placebo.14 Jirarattanaphochai et al. showed lower ODI and back and leg VAS scores at 3 months postoperatively in patients who received epidural methylprednisolone and bupivacaine; yet these were not statistically significant.12 Similar to the study performed by Haws et al., no significant difference was observed in the percentage of patients who achieved an MCID for ODI and back and leg VAS scores at 3 months after the surgery in the current study.24
No statistically significant difference was observed in the incidence of postoperative complications between the two groups during the 3 months after the surgery. Nevertheless, although the difference was not statistically significant, a higher incidence of SSI was noted in the group that received triamcinolone acetonide–soaked Gelfoam. In line with this finding, Haws et al. indicated that superficial wound infections tend to be more frequent in patients who received methylprednisolone-soaked Gelfoam and underwent MIS transforaminal lumbar interbody fusion; however, the difference was not significant.24 The most recent meta-analysis mentioned earlier, however, found no significant difference in postoperative complications such as infection between patients who received epidural steroids and those who received placebo (pooled risk ratio 0.92 [95% CI 0.47–1.83]).14 Some prior reports have consistently suggested a significant correlation between the use of the implanted instrument, as well as the performance of spinal fusion, and SSI after spinal procedures.26–28 This might explain the higher rate of SSI in the present investigation compared with prior studies on lumbar discectomy. Therefore, due in part to potential differences in the incidence of postoperative complications between the lumbar discectomy and fusion or between the MIS and conventional approaches, future studies are warranted to assess complications associated with epidural steroids in spinal fusion surgery.
Although the present study was the first to assess the efficacy of epidural triamcinolone acetonide–soaked Gelfoam specifically in patients undergoing posterolateral spinal fusion, there were some limitations. First, all patients were recruited at a single center, and the same surgeon and surgical team performed all operations. Thus, since the same surgical techniques were performed based on the surgeon’s preferences and experience, there might be a potential source of bias that could be addressed by future multicenter clinical trials. Second, patient-reported outcomes such as ODI and VAS as well as complication rates were assessed for 12 weeks postoperatively, which is a relatively short period of time to observe a minimal change in such outcomes. Future high-quality studies are needed to evaluate these outcomes over a long-term follow-up period. Third, the sample size was comparatively small to be used to evaluate the potential association between epidural corticosteroid administration and SSI. Accordingly, a much larger sample size is needed to assess this relationship, given the low incidence of this complication in elective spinal procedures according to prior reports.28,29 Fourth, although the clinical patient-reported outcome measures were not significantly different between the two groups at 12 weeks postoperatively, the effects of local administration of steroids on the rate of fusion were not assessed using radiographic evaluation in the present study. Future investigations are required to evaluate the effects of local administration of steroids on the bone union by performing radiographic studies with a longer follow-up period.
Conclusions
The local intraoperative epidural administration of triamcinolone acetonide did not affect the postoperative pain, cumulative morphine consumption, and patient-reported outcomes in patients undergoing posterolateral lumbar spinal fusion surgery in comparison with the placebo. Therefore, in contrast to current evidence regarding the efficacy of epidural use of steroids in conventional lumbar discectomy, the findings of this randomized controlled trial did not support the regular use of local epidural corticosteroids in posterolateral lumbar spinal fusion surgery. However, further studies are needed in order to validate these findings and evaluate the efficacy of epidural administration of steroids, specifically in patients undergoing spinal fusion.
Disclosures
The authors report no conflict of interest concerning the materials or methods used in this study or the findings specified in this paper.
Author Contributions
Conception and design: Oraee-Yazdani, Tavanaei, Ahmadi. Acquisition of data: Tavanaei, Ahmadi, Malekipour, Herfedoust Biazar, Keikhaee. Analysis and interpretation of data: Tavanaei, Ahmadi. Drafting the article: Tavanaei, Ahmadi, Malekipour, Oraii Yazdani. Critically revising the article: Oraee-Yazdani, Tavanaei, Ahmadi. Reviewed submitted version of manuscript: Oraee-Yazdani, Zali. Approved the final version of the manuscript on behalf of all authors: Oraee-Yazdani. Statistical analysis: Tavanaei. Administrative/technical/material support: Oraee-Yazdani, Ahmadi, Zali. Study supervision: Oraee-Yazdani, Zali.
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