Recruiting
Phase 3

Multimodal Analgesia

Sponsor:

Brigham and Women's Hospital

Code:

NCT07427043

Conditions

Opioid Consumption, Postoperative

Multimodal Analgesia

Robotic Assisted Laparoscopic Surgery

Robotic Assisted Laparoscopic Radical Prostatectomy

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 45+

Healthy Volunteers: Not accepted

Interventions

multimodal analgesia pathway with up-front small opioid prescription

multimodal analgesia pathway without up-front small opioid prescription

pre-implementation baseline including opioid

Study Details

Brief summary:

This prospective, interventional, open-label, phase 3 randomized study evaluates a multimodal analgesia discharge pathway to reduce automatic opioid prescribing following routine robotic-assisted laparoscopic prostatectomy (RALP). Patients are counseled on post-operative pain management and then may opt into or out of the study with randomization to discharge prescriptions including (A) multimodal plan with additional automatic opioid prescription or (B) multimodal plan alone and instruction to call phone line to request opioid prescription if pain management is insufficient. Additionally, a cohort of historical controls prior to implementation of the study is also prospectively assessed as a pre-study baseline. The primary outcome is postoperative opioid consumption. Secondary outcomes include bowel function recovery, unplanned care encounters including emergency department visits or postoperative phone calls, and same-day discharge rates.

Conditions

Opioid Consumption, Postoperative

Multimodal Analgesia

Robotic Assisted Laparoscopic Surgery

Robotic Assisted Laparoscopic Radical Prostatectomy

Prostate Cancer

Study ID

NCT07427043

Start date

Mar 1, 2026

Status verified date

May, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 45+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Men ≥45 years old
  • Undergoing Robotic Assisted Laparoscopic Prostatectomy (RALP) at BWH or BWFH
  • Able to provide informed consent

Exclusion Criteria:

  • Chronic kidney disease (baseline Cr >1.3)
  • NSAID contraindication/allergy
  • Regular opioid use or substance abuse prior to surgery
  • Inability to provide their own consent
  • Deviation from standard surgical practice for RALP (e.g. major complication requiring operative intervention that would result in patient no longer being considered a routine case)

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Pre-implementation historical baseline - Standard care prior to study intervention

Standard care prior to study intervention

active comparator: Post-implementation ROPES with multimodal analgesia pathway alone

Educated on post-op pain management, multimodal analgesia scripts given but no pre-emptive opioid script (to obtain opioid after discharge patient must call phone line to request).

active comparator: Post-implementation ROPES with multimodal analgesia pathway and up-front small opioid prescription

Educated on post-op pain management, multimodal analgesia scripts given and additionally given pre-emptive standard opioid script.

Interventions

multimodal analgesia pathway with up-front small opioid prescription

multimodal analgesia pathway including an up-front small opioid prescription

multimodal analgesia pathway without up-front small opioid prescription

multimodal analgesia pathway without up-front small opioid prescription

pre-implementation baseline including opioid

pre-implementation baseline including opioid

Primary outcome measure

  • Post-discharge opioid consumption (MME) [ Time Frame: 1-2 weeks after surgery ]

Central Contacts and Locations

Central contacts

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Brigham and Women's Faulkner Hospital

Recruiting

Boston, Massachusetts, United States, 02130

Contacts

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Multimodal Analgesia
  • Robotic Assisted Laparoscopic Radical Prostatectomy
  • Postoperative Opioid Consumption
  • Localized Prostate Cancer
  • Robotic Assisted Laparoscopic Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-05-22.