Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age45+
SponsorBrigham and Women's Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Men ≥45 years old

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

Able to provide informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Pre-implementation historical baseline - Standard care prior to study interventionActive comparator 1 intervention
Group B: Post-implementation ROPES with multimodal analgesia pathway aloneActive comparator 1 intervention
Group C: Post-implementation ROPES with multimodal analgesia pathway and up-front small opioid prescriptionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Post-discharge opioid consumption (MME)

assessed at post-operative visit

Time frame
1-2 weeks after surgery

Secondary outcomes

1

Return of bowel function

Time frame
1 week
2

Emergency Department visits

Time frame
30 days
3

Postoperative phone calls

Time frame
30 days
4

Same-day discharge rate

Index hospitalization

Time frame
Day of Surgery

Other outcomes

Sponsors and contacts

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