Clinical trial · Interventional
Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES): Implementation of an Opioid-free Multimodal Analgesia Discharge Pathway
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multimodal Analgesia | — | UNRESOLVED | — |
| Opioid Consumption, Postoperative | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Robotic Assisted Laparoscopic Radical Prostatectomy | — | UNRESOLVED | — |
| Robotic Assisted Laparoscopic Surgery | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| multimodal analgesia pathway without up-front small opioid prescription | Drug | — | UNRESOLVED |
| multimodal analgesia pathway with up-front small opioid prescription | Drug | — | UNRESOLVED |
| pre-implementation baseline including opioid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Pre-implementation historical baseline - Standard care prior to study intervention
- description
- Standard care prior to study intervention
- interventionNames
- Drug: pre-implementation baseline including opioid
- type
- ACTIVE_COMPARATOR
- label
- Post-implementation ROPES with multimodal analgesia pathway alone
- 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).
- interventionNames
- Drug: multimodal analgesia pathway without up-front small opioid prescription
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available