Single-dose epidural bupivacaine vs placebo after lumbar decompression surgery: A Randomized controlled trial

Introduction Adequate postoperative pain management following lumbar spinal decompression surgery is important as it will lead to early mobilization, less complications and shorter hospital stay. Opioid consumption should be limited due to their frequently accompanied side effects and their addictive nature. During the final phase of lumbar decompression surgery, the epidural space becomes easily accessible. This might be an ideal moment for surgeons to administer an epidural bolus of analgesia, as a safe and effective method for post-operative pain relief. Methods This is a double blind randomized controlled trial comparing a single intraoperative bolus of epidural analgesia using bupivacaine 0.25% to placebo (NaCl 0,9%) and its effect on postoperative pain following lumbar spinal decompression surgery. The primary outcome was the difference in NRS pain between the intervention and placebo groups during the first 48h after surgery. It was hypothesized that the intervention group will have lower postoperative NRS pain scores. Results Both the intervention group and the placebo group consisted of 20 randomized patients (N=40). We observed statistically significant lower NRS pain scores in the intervention group in comparison with the control group, with a difference of −1.9 (±1.1). The average pain score was lower in the intervention group at all postoperative time-points. Opioid consumption, quality of life and satisfaction were similar between study groups. No study related complications occurred, and complications rate did not differ between study groups. Conclusion This randomized controlled trial shows that administrating a bolus of intraoperative epidural bupivacaine is a safe and effective method in reducing early postoperative pain following lumbar decompression surgery. ### Competing Interest Statement The authors have declared that no competing interests exist. ### Clinical Trial Dutch National TrialRegistry (registration number: NL8030 currently transferred to the International Clinical Trial Registry Platform, ICTRP, https://trialsearch.who.int/Trial2.aspx?TrialID=NL8030 ### Clinical Protocols ### Funding Statement The author(s) received no specific funding for this work ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethical approval has been granted by the Medical Ethical Committee Zuyderland, Heerlen, the Netherlands (registration number: Z20190138). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All relevant data are within the manuscript and its Supporting Information files.