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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07308717
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Modification to Pre-operative Order Set — OTHER
    Modification to the pre-operative order set to remove gabapentin

Study Details

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.

Key Dates

Start date
Dec 16, 2025
Status verified
Dec 2025
Primary completion
Dec 16, 2027
Completion
Dec 16, 2027

Study Design

Enrollment
1,896 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control Arm
    Standard of care
  • Experimental: Intervention Arm
    The study intervention will consist of modification to the pre-operative order set to remove gabapentin.

Primary Outcome Measure

Amount of postoperative morphine milligram equivalents/MMEs required after mastectomy [ Time Frame: Up to 46 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
James Flory, MD
646-608-2684
Memorial Sloan Kettering Monmouth (Limited protocol activities)MiddletownNew Jersey07748
James Flory, MD
646-608-2684
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
James Flory, MD
646-608-2684
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)CommackNew York11725
James Flory, MD
646-608-2684
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
James Flory, MD
646-608-2684
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
James Flory, MD
646-608-2684
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
James Flory, MD
646-608-2684

Find similar trials in Basking Ridge, NJ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited protocol activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NY

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