Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

Mass General Brigham

Status and phase: Enrolling; Phase 3

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

Treatments: Drug: multimodal analgesia pathway with up-front small opioid prescription; Drug: multimodal analgesia pathway without up-front small opioid prescription; Drug: pre-implementation baseline including opioid

Study type: Interventional

Funder types: Other

Identifiers

NCT07427043

2024P001667

Details and patient eligibility

About

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.

Full description

The Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES) study will implement and systematically evaluate an opioid-free discharge pathway (OFP) after robotic-assisted laparoscopic prostatectomy (RALP) at Brigham and Women's Hospital and Brigham & Women's Faulkner Hospital. Patients are counseled pre-operatively and offered participation. Data will be compared across three prospectively studied groups: pre-implementation historical baseline (current practice), post-implementation ROPES with multimodal analgesia pathway alone (which requires patients to call phone line after discharge to request opioid if pain uncontrolled), and post-implementation ROPES with multimodal analgesia pathway plus up-front small opioid prescription. Standardized multimodal analgesic therapy is provided to all participating patients following study implementation, with opioids used only as needed. There is no change to the surgery and anesthesia plan (though standard care at our center includes injection of local anesthetic to incisions and ketorolac is encouraged at end of the procedure), and patients are allowed opioids while admitted to the post-op recovery area. The study aims to reduce postoperative opioid use while maintaining safety and quality outcomes; this will assess non-inferiority of ROPES OFP in comparison to standard opioid prescribing. Results may inform wider practice change within both our center, the field of urology, and perhaps surgical care more broadly.

Enrollment: 300 estimated patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Pre-implementation historical baseline - Standard care prior to study intervention

Active Comparator group

Description:

Standard care prior to study intervention

Treatment:

Drug: pre-implementation baseline including opioid

Post-implementation ROPES with multimodal analgesia pathway alone

Active Comparator group

Description:

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).

Treatment:

Drug: multimodal analgesia pathway without up-front small opioid prescription

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

Active Comparator group

Description:

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

Treatment:

Drug: multimodal analgesia pathway with up-front small opioid prescription