Opioid Consumption, PostoperativePhase 3ROPESNCT07427043
Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
A Phase 3 study testing multimodal analgesia pathway with up-front small opioid prescription, multimodal analgesia pathway without up-front small opioid prescription and pre-implementation baseline including opioid in people with Opioid Consumption, Postoperative and Multimodal Analgesia, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Opioid Consumption, Postoperative, Multimodal Analgesia, Robotic Assisted Laparoscopic Surgery
- What is being tested?
- multimodal analgesia pathway with up-front small opioid prescription, multimodal analgesia pathway without up-front small opioid prescription and pre-implementation baseline including opioid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2026to 30 Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men ≥45 years old
- Undergoing Robotic Assisted Laparoscopic Prostatectomy (RALP) at BWH or BWFH
- Able to provide informed consent
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Timothy Clinton, 617-732-6384, tclinton1@bwh.harvard.edu
- Recruiting
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, 02130
Timothy Clinton, 617-732-6384, tclinton1@bwh.harvard.edu
About this study
Official title: Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES): Implementation of an Opioid-free Multimodal Analgesia Discharge Pathway
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.
Read the detailed 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.
- Conditions
- Opioid Consumption, Postoperative, Multimodal Analgesia, Robotic Assisted Laparoscopic Surgery, Robotic Assisted Laparoscopic Radical Prostatectomy, Prostate Cancer
- Being tested
- multimodal analgesia pathway with up-front small opioid prescription, multimodal analgesia pathway without up-front small opioid prescription, pre-implementation baseline including opioid
- Keywords
- Multimodal Analgesia, Robotic Assisted Laparoscopic Radical Prostatectomy, Postoperative Opioid Consumption, Localized Prostate Cancer, Robotic Assisted Laparoscopic Surgery
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal analgesia pathway with up-front small opioid prescriptionDrug
multimodal analgesia pathway including an up-front small opioid prescription
multimodal analgesia pathway without up-front small opioid prescriptionDrug
multimodal analgesia pathway without up-front small opioid prescription
pre-implementation baseline including opioidDrug
pre-implementation baseline including opioid
| Study group | Role | What they receive |
|---|---|---|
| Pre-implementation historical baseline - Standard care prior to study intervention | Active comparator | Standard care prior to study intervention Receives: Drug: pre-implementation baseline including opioid |
| 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). Receives: 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 | Educated on post-op pain management, multimodal analgesia scripts given and additionally given pre-emptive standard opioid script. Receives: Drug: multimodal analgesia pathway with up-front small opioid prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-discharge opioid consumption (MME)
assessed at post-operative visit
Measured: 1-2 weeks after surgery
Secondary outcomes (4)
Return of bowel function
Measured: 1 week
Emergency Department visits
Measured: 30 days
Postoperative phone calls
Measured: 30 days
Same-day discharge rate
Index hospitalization
Measured: Day of Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Consumption, PostoperativeStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Clinton, Brigham and Women's Hospital
- Investigators
- Timothy Clinton, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427043
- Sponsor's protocol ID
- 2024P001667
- Acronym
- ROPES
- Status last verified
- May 2026
- First submitted
- 11 Feb 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES): Implementation of an Opioid-free Multimodal Analgesia Discharge Pathway
- ClinicalTrials.gov ID
- NCT07427043
- Acronym / sponsor ID
- ROPES / 2024P001667
- Conditions
- Opioid Consumption, Postoperative, Multimodal Analgesia, Robotic Assisted Laparoscopic Surgery, Robotic Assisted Laparoscopic Radical Prostatectomy, Prostate Cancer
- Keywords
- Multimodal Analgesia, Robotic Assisted Laparoscopic Radical Prostatectomy, Postoperative Opioid Consumption, Localized Prostate Cancer, Robotic Assisted Laparoscopic Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-implementation historical baseline - Standard care prior to study intervention | Active comparator | Drug: pre-implementation baseline including opioidStandard care prior to study intervention |
| Post-implementation ROPES with multimodal analgesia pathway alone | Active comparator | Drug: multimodal analgesia pathway without up-front small opioid prescriptionEducated 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 | Drug: multimodal analgesia pathway with up-front small opioid prescriptionEducated on post-op pain management, multimodal analgesia scripts given and additionally given pre-emptive standard opioid script. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men ≥45 years old
- Undergoing Robotic Assisted Laparoscopic Prostatectomy (RALP) at BWH or BWFH
- Able to provide informed consent
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multimodal analgesia pathway with up-front small opioid prescriptionmultimodal analgesia pathway including an up-front small opioid prescription | Drug | Post-implementation ROPES with multimodal analgesia pathway and up-front small opioid prescription |
| multimodal analgesia pathway without up-front small opioid prescriptionmultimodal analgesia pathway without up-front small opioid prescription | Drug | Post-implementation ROPES with multimodal analgesia pathway alone |
| pre-implementation baseline including opioidpre-implementation baseline including opioid | Drug | Pre-implementation historical baseline - Standard care prior to study intervention |
Primary outcome
Post-discharge opioid consumption (MME)
Time frame: 1-2 weeks after surgery
assessed at post-operative visit
4 secondary outcomes
Return of bowel function
Time frame: 1 week
Emergency Department visits
Time frame: 30 days
Postoperative phone calls
Time frame: 30 days
Same-day discharge rate
Time frame: Day of Surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Opioid Consumption, Postoperative
Not yet recruiting
Intravenous Lidocaine Versus Erector Spinae Plane Block After Lumbar Arthrodesis (LIBERA)
Single-level Lumbar Arthrodesis
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruitingPhase 4
Intravenous Dexamethasone for ESP Block Analgesia in Children Undergoing Idiopathic Scoliosis Surgery
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruiting
Perioperative Mirogabalin for Pain Relief After Modified Radical Mastectomy
Breast Cancer, Post Operative Pain
Not yet recruiting
Effect of Serratus and Pectoralis II Plane Block Versus Pectoralis II Alone on Acute Postoperative Pain After Mastectomy
Mastectomy, Mastectomy Plus Axillary Lymph Node Dissection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timothy Clinton, MD principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing multimodal analgesia pathway with up-front small opioid prescription, multimodal analgesia pathway without up-front small opioid prescription and pre-implementation baseline including opioid in people with Opioid Consumption, Postoperative and Multimodal Analgesia, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothy Clinton, MD (617-732-6384, tclinton1@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-discharge opioid consumption (MME) (time frame: 1-2 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.