Prostatectomy Clinical Trials

Clinical trials related to Prostatectomy Procedure

Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES): Implementation of an Opioid-free Multimodal Analgesia Discharge Pathway

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 45
Healthy Volunteers: f
View:

• Men ≥45 years old

• Undergoing Robotic Assisted Laparoscopic Prostatectomy (RALP) at BWH or BWFH

• Able to provide informed consent

Locations
United States
Massachusetts
Brigham and Women's Faulkner Hospital
RECRUITING
Boston
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Timothy Clinton, MD
tclinton1@bwh.harvard.edu
617-732-6384
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 300
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital

This content was sourced from clinicaltrials.gov

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