NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

NCT07427043

RecruitingPhase 3

Sponsor: Brigham and Women's Hospital

Conditions: Opioid Consumption, Postoperative, Multimodal Analgesia, Robotic Assisted Laparoscopic Surgery, Robotic Assisted Laparoscopic Radical Prostatectomy, Prostate Cancer

Interventions: multimodal analgesia pathway with up-front small opioid prescription, multimodal analgesia pathway without up-front small opioid prescription, pre-implementation baseline including opioid

Countries: United States

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 overview

Sex: MALE

Age: 45 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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)
Locations (2)
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States