Recruiting

Liposomal Bupivacaine vs. Bupivacaine with Dexmedetomidine

Sponsor:

United States Naval Medical Center, Portsmouth

Code:

NCT06252662

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Dexmedetomidine

Liposomal bupivacaine

Study Details

Brief 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.

Conditions

Breast Cancer

Study ID

NCT06252662

Start date

Oct 15, 2024

Status verified date

Nov, 2024

Completion date

Oct, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Dexmedetomidine

block duration extension additive

Liposomal bupivacaine

Control arm, comparison for block duration with dexmedetomidine

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Grant A Miller, DO

757-953-3238grant.a.miller7.mil@health.mil

Trevor O Elam, MD

757-953-3238trevor.o.elam.mil@health.mil

Locations

Naval Medical Center Portsmouth

Recruiting

Portsmouth, Virginia, United States, 23708

Contacts

Grant A Miller, LCDR, DO, Anesthesiologist

2678722411grant.a.miller7.mil@health.mil

More Information

Sponsor

United States Naval Medical Center, Portsmouth

Last update posted

Nov 19, 2024

Last verified

Nov, 2024

Keywords

  • erector spinae plane block
  • bupivacaine
  • morphine equivalents
  • pain score
  • post-operative pain
  • post-surgical pain
  • liposomal bupivacaine
  • Exparel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by United States Naval Medical Center, Portsmouth on 2024-11-19.