RECRUITING

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

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Conditions

Breast Cancererector spinae plane blockbupivacainemorphine equivalentspain scorepost-operative painpost-surgical painliposomal bupivacaineExparel

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in an Erector Spinae Plane Block for Mastectomies in Cancer Patients: a Randomized Control Trial

Quick Facts

Study Start:2024-10-15
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06252662

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients requiring any variation of mastectomy with or without axillary lymph node dissection.
  2. * Patient agrees to a peripheral nerve block.
  3. * Patient agrees to be a study participant.
  4. * APS team believes a peripheral nerve block would be appropriate for the patient after reviewing medical/surgical history.
  5. * Surgeon agrees with the block plan by APS.
  1. * Patient declines a peripheral nerve block.
  2. * Patient declines to be a study participant.
  3. * APS team believes a peripheral nerve block is not clinically indicated.
  4. * Surgeon does not want a peripheral nerve block.
  5. * Patient has allergy to local anesthestic.
  6. * Patient has an active infection at the site of the peripheral nerve block.
  7. * Patient with pre-existing neural deficits along the distribution of the block.
  8. * Patient with coagulopathy.
  9. * Patient taking antithrombotic drugs outside the ASRA guidelines.
  10. * Patients weight is less that 50 kg due to concerns for local anesthetic toxicity syndrome.

Contacts and Locations

Study Contact

Grant A Miller, DO
CONTACT
757-953-3238
grant.a.miller7.mil@health.mil
Trevor O Elam, MD
CONTACT
757-953-3238
trevor.o.elam.mil@health.mil

Study Locations (Sites)

Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
United States

Collaborators and Investigators

Sponsor: United States Naval Medical Center, Portsmouth

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-15
Study Completion Date2025-10

Study Record Updates

Study Start Date2024-10-15
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Breast Cancer