Liposomal Bupivacaine vs Bupivacaine With Dexmedetomidine in Erector Spinae Plane Blocks for Mastectomies

February 8, 2024 updated by: Grant Miller, United States Naval Medical Center, Portsmouth

Liposomal Bupivacaine vs Bupivacaine With Dexmedetomidine in an Erector Spinae Plane Block for Mastectomies in Cancer Patients: A Randomized Control Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Performance of a single-blinded randomized control trial to evaluate effectiveness of postoperative pain control in erector spinae plane blocks with bupivacaine with liposomal bupivacaine as the control versus bupivacaine with dexmedetomidine. Plan to randomize patients by alternating months, so that odd months' patients will receive bupivacaine 0.25% with liposomal bupivacaine in the erector spinae plane block. Even months patients will receive bupivacaine 0.25% with dexmedetomidine in the erector spinae plane block.

Block will be performed with ultrasound by the APS team. A time out confirming location of surgery, allergies, consents completed prior to start of the block. Patients will be monitored with 5 lead electrocardiography, non-invasive blood pressure, and pulse oximetry. After skin wheal with 1% lidocaine via 25-27 g needle and echogenic 20 g needle will be utilized to perform the block. The needle will be placed under direct ultrasound visualization into the ESP plane. The plane will be hydro dissected with normal saline to confirm needle tip has accessed the erector spinae plane. The local anesthetic will be given in a total of 0.2 ml/kg up to 20 mls (selected based on the study group placement) and aspiration will occur every 5 mls during the block. This will be repeated on the second side if a bilateral block is indicated in based on the surgical consent. All patients will receive 10 mg IV dexamethasone post-induction of anesthesia.

While the patient is in patient pain scores and milligrams of morphine equivalence (MMEs) will be collected every 6 hours based on charting by the nurses providing care starting from time "0" in the PACU after surgery, up until discharge. Then to obtain pain scores up to 72 hours after surgery, patients will be called at home after 72 hours and asked what their pain scores had been daily since discharge and a total of tabs taken daily.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Liposomal bupivacaine
Control arm, comparison for block duration with dexmedetomidine
Other Names:
  • Exparel
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.
Drug: Dexmedetomidine
block duration extension additive
Other Names:
  • Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Is bupivacaine with dexmedetomidine superior to liposomal bupivacaine in both density and duration?
Time Frame: 96 hours
Control group erector spinae plane block with liposomal bupivacaine is less dense and not as long lasting as bupivacaine with dexmedetomidine experimental group. Will investigate initial VAS pain scores to determine how effective the block is after surgery and every 6 hours while in patient. Additionally, calling the patient discharging after 96 hours from the time of the block and collect daily pain scores from the patient. This is to establish which group had best pain scores throughout and longest duration of lowest pain scores.
96 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate oral milligram of morphine equivalent.
Time Frame: 96 hours
Same control and experimental group assessing for MME reduction between groups. Will investigate milligram of morphine equivalent every 6 hours to see how much each group requires. In particular looking for increasing trend in morphine equivalence over time. Additionally, calling the patient discharging after 96 hours from the time of the block and collect daily opioid medications taken by the patient and converting to milligram morphine equivalents. This is to establish which group has taken the least amount of morphine equivalents throughout the duration of the block, as an indication to the duration of optimum benefit of the block.
96 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first opioid administration
Time Frame: 24 hours
Determine if there is a difference in time to first opioid dose after surgery when block is provided before surgery. To determine if there is a difference in the quality of the block after the surgery requiring earlier administration of opioids, as is expected with less dense block having more increased pain.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Naval Medical Center, Portsmouth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

January 31, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-18229

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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