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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 4

Conditions: Breast Cancer

Treatments: Other: Modification to Pre-operative Order Set

Study type: Interventional

Funder types: Other

Identifiers

NCT07308717

25-183

Details and patient eligibility

About

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.

Enrollment: 1,896 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,896 participants in 2 patient groups

Control Arm

No Intervention group

Description:

Standard of care

Intervention Arm

Experimental group

Description:

The study intervention will consist of modification to the pre-operative order set to remove gabapentin.

Treatment:

Other: Modification to Pre-operative Order Set