Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in Erector Spinae Plane Blocks for Mastectomies
United States Naval Medical Center, Portsmouth · NCT06252662
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 4
- Target enrollment
- 200
- US sites recruiting
- 1
- Study start
- October 15, 2024
- Record last updated
- November 19, 2024
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Dexmedetomidine; Liposomal bupivacaine
Conditions: Breast Cancer
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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 Criteria
- 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.
Recruiting US locations
Naval Medical Center Portsmouth
Portsmouth, VA 23708
Site contact: Grant A Miller, LCDR, DO, Anesthesiologist · 2678722411 · grant.a.miller7.mil@health.mil
Study contacts (from the official record)
- Grant A Miller, DO · 757-953-3238 · grant.a.miller7.mil@health.mil
- Trevor O Elam, MD · 757-953-3238 · trevor.o.elam.mil@health.mil
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