Perioperative subcutaneous methylnaltrexone does not enhance gastrointestinal recovery after posterior short-segment spinal arthrodesis surgery: a randomized controlled trial

Spine J. 2022 Mar;22(3):444-453. doi: 10.1016/j.spinee.2021.08.004. Epub 2021 Aug 19.

Abstract

Background context: Postoperative ileus is a major barrier to gastrointestinal recovery following surgery. Opioid analgesics likely play an important causative role, particularly in spinal or orthopedic surgeries not involving bowel manipulation. Methylnaltrexone, a peripherally-acting µ-opioid receptor antagonist, is a potential prophylactic treatment.

Purpose: To assess the influence of perioperative subcutaneous methylnaltrexone administration on gastrointestinal recovery following short-segment lumbar arthrodesis surgeries.

Design: This is a randomized, double-blind, controlled trial.

Patient sample: Eligible patients undergoing posterior short-segment lumbar arthrodesis surgeries at a single institution between February 2019 and April 2021 were enrolled in this study.

Outcome measures: The primary outcome measure was time-to-first bowel movement. Secondary outcome measures included time-to-discharge/discharge eligibility. Exploratory outcome measures included daily postoperative opioid consumption and pain scores.

Methods: In this study, eligible patients were enrolled to receive either methylnaltrexone or placebo perioperatively. Time-to-bowel movement, time-to-discharge/discharge eligibility, intra and postoperative analgesic administration, and pain scores were recorded and compared.

Results: Eighty two patients in total were enrolled; 41 to the methylnaltrexone and 41 to the placebo group. Both groups were similar in their baseline characteristics. There was no difference in median (range) time-to-bowel movement between the 2 groups [61.8 hours (35.7-93.6) versus 50.7 hours (17.8-110.8), p = .391]. There was also no difference in time-to-discharge/discharge eligibility [105.0 hours (81.0 - 201.3) versus 90.7 (77.5 - 184.5), p=.784]. Finally, there were no differences in either postoperative opioid consumption or numeric rating scores for back, leg, or abdominal pain on postoperative days 0 to 4 (p>.05).

Conclusions: Methylnaltrexone did not accelerate gastrointestinal recovery and did not affect opioid consumption or pain scores following short-segment spinal surgery as compared to placebo. Additional studies will be needed to identify effective opioid receptor antagonist dosing regimens for patients undergoing either short- or long-segment spinal arthrodesis procedures.

Keywords: Enhanced Recovery After Surgery; Intraoperative Opioids; Methylnaltrexone; Postoperative Ileus; Randomized Clinical Trial; Spinal Surgery.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Analgesics, Opioid / therapeutic use
  • Arthrodesis
  • Double-Blind Method
  • Humans
  • Naltrexone* / adverse effects
  • Naltrexone* / analogs & derivatives
  • Narcotic Antagonists / adverse effects
  • Pain, Postoperative / drug therapy
  • Quaternary Ammonium Compounds* / adverse effects
  • Treatment Outcome

Substances

  • Analgesics, Opioid
  • Narcotic Antagonists
  • Quaternary Ammonium Compounds
  • methylnaltrexone
  • Naltrexone