Comparison of a Non-Opioid Multimodal Analgesia Protocol with Opioid-Based Patient-Controlled Analgesia for Pain Control Following Robot-Assisted Radical Prostatectomy: A Randomized, Non-Inferiority Trial

Abstract

Background

Opioid use after surgery is a potential contributor to the opioid epidemic. An adequate pain control method after surgery while minimizing opioid exposure is needed. This study aimed to compare the effect of non-opioid multimodal analgesia (NOMA) protocol with opioid-based patient-controlled analgesia (PCA) for pain relief after robot-assisted radical prostatectomy (RARP).

Methods

This prospective randomized, open, non-inferiority trial included 80 patients scheduled for RARP. The NOMA group received pregabalin, paracetamol, bilateral quadratus lumborum block, and pudendal nerve block. PCA group received PCA. Pain scores, postoperative nausea and vomiting, opioid requirements, and quality of recovery were recorded 48 hours after surgery.

Results

We found no significant differences in pain scores. The mean difference in pain score during rest at 24 h was 0.5 (95% CI −0.5 to 2.0). This result demonstrated the non-inferiority of NOMA protocol to PCA at our non-inferiority margin (−1). In addition, 23 patients in the NOMA group did not receive any opioid agonist for 48 h after surgery. Recovery of bowel function was also faster in the NOMA group than in the PCA group (25.0 hours vs 33.4 hours, p = 0.01).

Limitations

We did not evaluate whether our NOMA protocol could decrease the incidence of new continuous opioid use after surgery.

Conclusion

NOMA protocol successfully controlled postoperative pain and was non-inferior to morphine-based PCA regarding patient-reported pain intensity. It also promoted recovery of bowel function and decreased postoperative nausea and vomiting.

Keywords:

• multimodal analgesia
• opioid sparing
• postoperative pain
• robot-assisted radical prostatectomy

Data Sharing Statement

The data supporting this study’s findings will be available after de-identification to investigators who want to use the data. Data will be available up to 60 months from the date of issue. We will provide the data after the approval of the review committee. Data sharing proposals should be directed to [email protected] with a data access agreement.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

The authors report no conflicts of interest in this work.

Additional information

Funding

This research received no specific grant from the public, commercial, or not-for-profit funding agencies.