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RecruitingPhase 4

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Block will be performed with ultrasound by the Acute Pain Service team."
  • "The needle will be placed under direct ultrasound visualization into the erector spinae plane."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two numbing drug options for pain relief after a mastectomy, surgery to remove a breast for cancer. It tests liposomal bupivacaine against bupivacaine with dexmedetomidine, given as a nerve block near the spine. Researchers will compare how long pain relief lasts and when and how much opioid pain medicine patients need while in the hospital.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You need a mastectomy, with or without removal of lymph nodes in the armpit.
  • You agree to a nerve block, an injection that numbs an area to reduce pain.
  • You agree to join the study.
  • The pain care team reviews your health and surgery history and decides a nerve block is right for you.
  • Your surgeon agrees with the nerve block plan.

Who can't join

  • You do not want a nerve block or do not want to join the study.
  • The pain care team decides a nerve block is not right for you, or your surgeon does not want you to have one.
  • You are allergic to local anesthetics, medicines that numb an area.
  • You have an active infection where the nerve block would be given.
  • You already have nerve problems in the area the block would numb.
  • You have a blood-clotting disorder.
  • You take medicines that prevent blood clots in a way that does not meet ASRA safety guidelines for nerve blocks.
  • You weigh less than 50 kilograms (about 110 pounds), because of concerns about harmful effects from the numbing medicine.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

VA