Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in an Erector Spinae Plane Block for Mastectomies in Cancer Patients: a Randomized Control Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• Patients requiring any variation of mastectomy with or without axillary lymph node dissection.
• Patient agrees to a peripheral nerve block.
• Patient agrees to be a study participant.
• APS team believes a peripheral nerve block would be appropriate for the patient after reviewing medical/surgical history.
• Surgeon agrees with the block plan by APS.
Locations
United States
Virginia
Naval Medical Center Portsmouth
RECRUITING
Portsmouth
Contact Information
Primary
Grant A Miller, DO
grant.a.miller7.mil@health.mil
757-953-3238
Backup
Trevor O Elam, MD
trevor.o.elam.mil@health.mil
757-953-3238
Time Frame
Start Date:2024-10-15
Estimated Completion Date:2025-10
Participants
Target number of participants:200
Treatments
Active_comparator: Liposomal bupivacaine and bupivacaine plain erector spinae plane block
Erector spinae plane block performed on the surgical side (left, right or bilateral) as appropriate based on planned surgical consent. Utilizing ultrasound to see the fascial layers and guide the needle placement under direct visualization. Block will include 1.33% liposomal bupivacaine 10ml plus 0.25% bupivacaine plain 20 ml per side of the block.
Experimental: Bupivacaine plain with dexmedetomidine
Erector spinae plane block performed on the surgical side (left, right or bilateral) as appropriate based on planned surgical consent. Utilizing ultrasound to see the fascial layers and guide the needle placement under direct visualization. Block will include 0.25% bupivacaine plain 30 ml plus dexmedetomidine 0.5 mcg/kg per side of the block.