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RecruitingInterventionalPhase 4

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

NCT ID: NCT07308717Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2025-12-30

Summary

This study aims to assess whether gabapentin should be a standard component of peri-operative pain control in mastectomy patients at Memorial Sloan Kettering Cancer Center.

Arms & interventions

  • OtherModification to Pre-operative Order Set

    Modification to the pre-operative order set to remove gabapentin

Outcome measures

Primary

  • Amount of postoperative morphine milligram equivalents/MMEs required after mastectomy

    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

    Time frame: Up to 46 months

Eligibility criteria

Sex: AllAge: 18 Years to 65 YearsHealthy volunteers: No
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

Study locations (7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

Recruiting
James Flory, MD · Contact

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, 07748

Recruiting
James Flory, MD · Contact

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

Recruiting
James Flory, MD · Contact

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)

Commack, New York, 11725

Recruiting
James Flory, MD · Contact

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

Recruiting
James Flory, MD · Contact

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
James Flory, MD · Contact

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553

Recruiting
James Flory, MD · Contact
Gabapentin And Breast Surgery Decision Architecture Randomization Trial (GABS-DART) Protocol | Cancerify