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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07308717

Enrollment

1896

Registered

2025-12-30

Start date

2025-12-16

Completion date

2027-12-16

Last updated

2025-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer, unilateral mastectomy, bilateral mastectomy, 25-183, Memorial Sloan Kettering Cancer Center

Brief 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.

Interventions

OTHERModification to Pre-operative Order Set

Modification to the pre-operative order set to remove gabapentin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Amount of postoperative morphine milligram equivalents/MMEs required after mastectomy	Up 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

Countries

United States

Contacts

Primary ContactJames Flory, MD

floryj@mskcc.org646-608-2914

Backup ContactAndrew Vickers, PhD

vickersa@MSKCC.ORG646-227-3678

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026