Alvimopan for the reduction of postoperative ileus after long posterior spinal fusion: placebo-controlled double-blind randomized trial.

OBJECTIVE: The aim of this study was to evaluate the efficacy of alvimopan administration after posterior spinal fusion (PSF) in adult spine surgery patients who are taking opioid agents.

METHODS: In this placebo-controlled, double-blind randomized trial, PSF patients were randomized in blocks to placebo or study drug. Primary and secondary outcome measures were return to normal bowel function, including time to passage of flatus and stool, time to tolerance of oral nutrition, and time to hospital discharge. Patients were included regardless of chronic opioid consumption status.

RESULTS: Thirty-one patients provided consent for participation, and 26 patients (13 per group) completed the study. There were no differences between groups with respect to time to flatus, time to bowel movement, time to oral nutrition tolerance, and time to discharge. Calculated effect sizes favored placebo for all interventions.

CONCLUSIONS: Alvimopan did not hasten return to bowel function for any primary or secondary outcome measures when compared with placebo for patients undergoing PSF. There were no adverse events related to alvimopan, including for patients with chronic opioid consumption. While underpowered to determine a statistical difference, it is unlikely that a clinically relevant effect exists.