Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in Erector Spinae Plane Blocks for Mastectomies
NCT06252662 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2024-11-19
Summary
Perform a comparison of effective pain relief duration between liposomal bupivacaine and dexmedetomidine when added to bupivacaine in a block for mastectomy for cancer surgery. The erector spinae plane block is a well-established block that is utilized for post operative pain control for procedures performed on the soft tissue of the chest and chest wall as well as intrathoracic procedures. The goal is comparison of the effective duration of both study groups to determine if there is a significant difference in time and amount of post operative opioids required which admitted to hospital.
Conditions
Interventions
- DRUG
-
Dexmedetomidine
block duration extension additive
- DRUG
-
Liposomal bupivacaine
Control arm, comparison for block duration with dexmedetomidine
Sponsors & Collaborators
-
United States Naval Medical Center, Portsmouth
lead FED
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-10-15
- Primary Completion
- 2025-07-31
- Completion
- 2025-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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