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RecruitingAccepts healthy volunteersPhase 4

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

United States Naval Medical Center, Portsmouth · NCT06252662

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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
All pain studies in Virginia →
Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in… (NCT06252662) | Bored Studies