Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07427043
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
MALE
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • multimodal analgesia pathway with up-front small opioid prescription — DRUG
    multimodal analgesia pathway including an up-front small opioid prescription
  • multimodal analgesia pathway without up-front small opioid prescription — DRUG
    multimodal analgesia pathway without up-front small opioid prescription
  • pre-implementation baseline including opioid — DRUG
    pre-implementation baseline including opioid

Study Details

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.

Key Dates

Start date
Mar 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's Faulkner HospitalBostonMassachusetts02130
Timothy Clinton
[email protected]
617-732-6384
Brigham and Women's HospitalBostonMassachusetts02115
Timothy Clinton
[email protected]
617-732-6384

Find similar trials in Boston, MA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Brigham and Women's Faulkner Hospital· Boston, MABrigham and Women's Hospital· Boston, MA

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