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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-implementation historical baseline - Standard care prior to study intervention | Active Comparator | Standard care prior to study intervention |
|
| Post-implementation ROPES with multimodal analgesia pathway alone | Active Comparator | 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). |
|
| Post-implementation ROPES with multimodal analgesia pathway and up-front small opioid prescription | Active Comparator | Educated on post-op pain management, multimodal analgesia scripts given and additionally given pre-emptive standard opioid script. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multimodal analgesia pathway with up-front small opioid prescription | Drug | multimodal analgesia pathway including an up-front small opioid prescription |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-discharge opioid consumption (MME) | assessed at post-operative visit | 1-2 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Return of bowel function | 1 week | |
| Emergency Department visits | 30 days | |
| Postoperative phone calls |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Timothy Clinton, MD | Contact | 617-732-6384 | tclinton1@bwh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Timothy Clinton, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
This trial is being performed at within a single institution (Mass General Brigham) at two of it's constituent sites (BWH and BWFH), as part of IRB approval of the study decision was for privacy policy that only aggregated data would be intended to be shared outside the institutions system and any IPD would be solely stored on HIPAA compliant servers at the facility. De=identified or aggregated data would be permitted to be shared so long as subjects could not be identified.
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| 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 |
|
| 30 days |
| Same-day discharge rate | Index hospitalization | Day of Surgery |
| Brigham and Women's Faulkner Hospital | Recruiting | Boston | Massachusetts | 02130 | United States |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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