Status:
RECRUITING
Nerve Blocks in Alloplastic Breast Reconstruction
Lead Sponsor:
University of British Columbia
Conditions:
Surgery, Plastic
Mastectomy
Eligibility:
FEMALE
19+ years
Phase:
NA
Brief Summary
Pain management is a major concern in oncologic breast surgery and reconstruction. Significant risks for acute and chronic pain after surgery might be reduced through improved pain control pre-operati...
Detailed Description
OBJECTIVES The primary objectives of the pilot trial are to demonstrate feasibility of recruitment and to demonstrate efficacy potential. The primary objectives of the definitive trial are to determi...
Eligibility Criteria
Inclusion
- Patients must be female, and at least 19 years old.
- Patients must be ASA grade I or II.
- Patients must be undergoing total mastectomy with IBR using tissue expander or implant, with or without axillary surgery.
Exclusion
- Patients have a known contraindication for a regional block: known coagulation disorder, treatment with anticoagulants, infection at the injection site, known allergy to medication in the study.
- Patients who are pregnant at the time of surgery.
- Patients having bilateral mastectomy and immediate alloplastic breast reconstruction (as only one side can be blocked to prevent local anesthesia toxicity).
- Patients with ASA Class III or IV.
- Patients with BMI\>35kg/m2.
- Patients weighing less than 50kg.
- Patients living/staying outside of 1-hour driving distance from hospital.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04860843
Start Date
May 1 2021
End Date
August 1 2024
Last Update
January 8 2024
Active Locations (1)
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1
Mount St Joseph Hospital
Vancouver, British Columbia, Canada, V5T 3N4