Gabapentin and Breast Surgery Pain Control Study

This study, called GABS-DART, is looking at whether gabapentin (a medication sometimes used for pain) should be a standard part of pain control for patients having mastectomy (breast removal surgery) at Memorial Sloan Kettering Cancer Center. The study will compare how much pain medication (measured in morphine milligram equivalents or MMEs) is needed after surgery when gabapentin is removed from the pre-operative order set. You may be able to join if you are between 18 and 65 years old and are having a mastectomy at the Josie Robertson Surgical Center. The study plans to enroll 1896 participants, but its current status is unclear.

Study design
This is an interventional study that plans to enroll 1896 participants. It involves a modification to the pre-operative order set to remove gabapentin.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your need for pain medication will be measured for up to 46 months after surgery.

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NCT07308717

Gabapentin And Breast Surgery Decision Architecture Randomization Trial (GABS-DART) Protocol

Recruiting
PHASE4Ages 18–65InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~1,896 participants
Updated 2025-12-30 on ClinicalTrials.gov
What's tested:Modification to Pre-operative Order Set

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Amount of postoperative morphine milligram equivalents/MMEs required after mastectomy
Measured over Up to 46 months
Breast Cancer
7 sites across 2 states
New York4
New Jersey3
  • James Flory, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

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Eligibility criteria

Inclusion

Age 18 to 65 years
Undergoing ambulatory extended recover (AXR) mastectomy (bilateral or unilateral) at the Josie Robertson Surgical Center (JSRC)

Exclusion

None
  • Amount of postoperative morphine milligram equivalents/MMEs required after mastectomyUp to 46 months

    Determine the effect of peri-operative gabapentin use on pain control in the PACU operationalized as the top quartile of postoperative morphine milligram equivalents/MMEs required in participants undergoing mastectomy