Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in Erector Spinae Plane Blocks for Mastectomies

Part of paid clinical trials in Portsmouth, Virginia.

Sponsor
United States Naval Medical Center, Portsmouth
Study ID
NCT06252662
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Dexmedetomidine — DRUG
    block duration extension additive
  • Liposomal bupivacaine — DRUG
    Control arm, comparison for block duration with dexmedetomidine

Study Details

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.

Key Dates

Start date
Oct 15, 2024
Status verified
Nov 2024
Primary completion
Jul 31, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Is bupivacaine with dexmedetomidine superior to liposomal bupivacaine in both density and duration? [ Time Frame: 96 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Naval Medical Center PortsmouthPortsmouthVirginia23708
Grant A Miller, LCDR, DO, Anesthesiologist
[email protected]
2678722411

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