NCT06252662

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
United States Naval Medical Center, Portsmouth
~200 participants
Updated 2024-11-19 on ClinicalTrials.gov
What's tested:DexmedetomidineLiposomal bupivacaine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Is bupivacaine with dexmedetomidine superior to liposomal bupivacaine in both density and duration?
Measured over 96 hours
Breast Cancer
1 sites across 1 states
Virginia1

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Eligibility criteria

Inclusion

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.

Exclusion

Patient declines a peripheral nerve block.
Patient declines to be a study participant.
APS team believes a peripheral nerve block is not clinically indicated.
Surgeon does not want a peripheral nerve block.
Patient has allergy to local anesthestic.
Patient has an active infection at the site of the peripheral nerve block.
Patient with pre-existing neural deficits along the distribution of the block.
Patient with coagulopathy.
Patient taking antithrombotic drugs outside the ASRA guidelines.
Patients weight is less that 50 kg due to concerns for local anesthetic toxicity syndrome.
  • Is bupivacaine with dexmedetomidine superior to liposomal bupivacaine in both density and duration?96 hours

    Control group erector spinae plane block with liposomal bupivacaine is less dense and not as long lasting as bupivacaine with dexmedetomidine experimental group. Will investigate initial visual analog scale (VAS) pain scores to determine how effective the block is after surgery and every 6 hours while in patient. Additionally, calling the patient discharging after 96 hours from the time of the block and collect daily pain scores from the patient. This is to establish which group had best pain scores throughout and longest duration of lowest pain scores.