Actively Recruiting

Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
NCT06252662

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

Led by United States Naval Medical Center, Portsmouth · Updated on 2024-11-19

200

Participants Needed

1

Research Sites

50 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Acute Pain Service team believes a peripheral nerve block is appropriate after reviewing medical and surgical history
  • Surgeon agrees with the peripheral nerve block plan by the Acute Pain Service team
Not Eligible

You will not qualify if you...

  • Patient declines a peripheral nerve block
  • Patient declines to be a study participant
  • Acute Pain Service team believes a peripheral nerve block is not clinically indicated
  • Surgeon does not want a peripheral nerve block
  • Patient has allergy to local anesthetic
  • Patient has an active infection at the site of the peripheral nerve block
  • Patient has pre-existing neural deficits along the block distribution
  • Patient has coagulopathy
  • Patient is taking antithrombotic drugs outside ASRA guidelines
  • Patient weighs less than 50 kg due to risk of local anesthetic toxicity syndrome

AI-Screening

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Trial Site Locations

Total: 1 location

1

Naval Medical Center Portsmouth

Portsmouth, Virginia, United States, 23708

Actively Recruiting

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Research Team

G

Grant A Miller, DO

CONTACT

T

Trevor O Elam, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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