Gabapentin for perioperative pain control in mastectomy
Official title: Gabapentin And Breast Surgery Decision Architecture Randomization Trial (GABS-DART) Protocol
Run by Memorial Sloan Kettering Cancer Center · NCT07308717 · Data updated 2026-11-12
This trial will test whether a pre-operative dose of gabapentin reduces pain and opioid use for adults 18–65 having ambulatory mastectomy at Memorial Sloan Kettering.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 1896 (estimated) |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Status | Recruiting |
| Started | December 16, 2025 |
| Main results expected | December 16, 2027 |
| Study ends | December 16, 2027 |
| Registry record updated | December 30, 2025 |
| Trial ID | NCT07308717 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18–65 scheduled for ambulatory extended recovery (AXR) unilateral or bilateral mastectomy at the Josie Robertson Surgical Center within the MSK system.
✕Probably not a fit
Patients older than 65, those not undergoing AXR mastectomy, those with contraindications to gabapentin (for example severe kidney disease or allergy), or those treated entirely outside the MSK system are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 4 interventional trial randomizes a modification to the pre-operative order set to include gabapentin as part of peri-operative analgesia for patients undergoing ambulatory extended recovery (AXR) mastectomy at MSK. Eligible adults (18–65) having unilateral or bilateral mastectomy at the Josie Robertson Surgical Center will be exposed to the modified order set as part of routine clinical workflow. Key outcomes include postoperative pain scores, opioid consumption, and gabapentin-related adverse events captured through perioperative care. The aim is to see whether making gabapentin a default in the order set improves pain control and reduces opioid use compared with usual ordering.
Why it matters
Potential benefit: If successful, patients could have better post-mastectomy pain control and lower opioid needs, potentially making gabapentin a routine part of peri-operative care.
How similar studies have gone: Previous perioperative studies of gabapentin have shown mixed results for reducing postoperative pain and opioid use, while using order-set default changes as the intervention is a relatively novel implementation approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 to 65 years * Undergoing ambulatory extended recover (AXR) mastectomy (bilateral or unilateral) at the Josie Robertson Surgical Center (JSRC) Exclusion Criteria: * None
Where it's running
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Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States Recruiting -
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States Recruiting -
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States Recruiting -
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Commack, New York, United States Recruiting -
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States Recruiting -
Memorial Sloan Kettering Cancer Center
New York, New York, United States Recruiting
Show 1 more location
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Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States Recruiting
Study contacts
- Principal investigator: James Flory, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: James Flory, MD
- Email: floryj@mskcc.org
- Phone: 646-608-2914
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.