Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in Erector Spinae Plane Blocks for Mastectomies
Recruiting · NCT06252662 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Naval Medical Center Portsmouth - Portsmouth, Virginia, United States