Clinical trial · Interventional
Gabapentin And Breast Surgery Decision Architecture Randomization Trial (GABS-DART) Protocol
NCT07308717CI-TRIAL-00099803recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Modification to Pre-operative Order Set | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- Standard of care
- type
- EXPERIMENTAL
- label
- Intervention Arm
- description
- The study intervention will consist of modification to the pre-operative order set to remove gabapentin.
- interventionNames
- Other: Modification to Pre-operative Order Set
Primary outcomes (1)
- measure
- Amount of postoperative morphine milligram equivalents/MMEs required after mastectomy
- timeFrame
- Up to 46 months
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.