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

NCT06252662 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 23-18229
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Is bupivacaine with dexmedetomidine superior to liposomal bupivacaine in both density and duration?

  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 visual analog scale (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 Outcomes (1)

• Evaluate oral milligram of morphine equivalent (MME).

  96 hours

Other Outcomes (1)

• Time to first opioid administration

  24 hours

Study Arms (2)

Liposomal bupivacaine and bupivacaine plain erector spinae plane block

ACTIVE COMPARATOR

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

Bupivacaine plain with dexmedetomidine

EXPERIMENTAL

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

Interventions

Dexmedetomidine DRUG

block duration extension additive

Also known as: Precedex

Bupivacaine plain with dexmedetomidine

Liposomal bupivacaine DRUG

Control arm, comparison for block duration with dexmedetomidine

Also known as: Exparel

Liposomal bupivacaine and bupivacaine plain erector spinae plane block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• United States Naval Medical Center, Portsmouth: lead

Study Sites (1)

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

RECRUITING

Related Publications (12)

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7.

  PMID: 26742998 BACKGROUND

• Haddock NT, Garza R, Boyle CE, Liu Y, Teotia SS. Defining Enhanced Recovery Pathway with or without Liposomal Bupivacaine in DIEP Flap Breast Reconstruction. Plast Reconstr Surg. 2021 Nov 1;148(5):948-957. doi: 10.1097/PRS.0000000000008409.

  PMID: 34705768 BACKGROUND

• Schnabel A, Reichl SU, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and safety of paravertebral blocks in breast surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2010 Dec;105(6):842-52. doi: 10.1093/bja/aeq265. Epub 2010 Oct 14.

  PMID: 20947592 BACKGROUND

• Leong RW, Tan ESJ, Wong SN, Tan KH, Liu CW. Efficacy of erector spinae plane block for analgesia in breast surgery: a systematic review and meta-analysis. Anaesthesia. 2021 Mar;76(3):404-413. doi: 10.1111/anae.15164. Epub 2020 Jul 1.

  PMID: 32609389 BACKGROUND

• Brown CA, Ghanouni A, Williams R, Payne SH, Ghareeb PA. Safety and Efficacy of Liposomal Bupivacaine Supraclavicular Nerve Blocks in Open Treatment of Distal Radius Fractures: A Perioperative Pain Management Protocol. Ann Plast Surg. 2023 Jun 1;90(6S Suppl 4):S332-S336. doi: 10.1097/SAP.0000000000003464. Epub 2023 Jan 31.

  PMID: 36752544 BACKGROUND

• Malan SH, Jaroszewski DE, Craner RC, Weis RA, Murray AW, Meinhardt JR, Girardo ME, Abdelrazek AS, Borah BJ, Dholakia R, Smith BB. Erector Spinae Plane Block With Liposomal Bupivacaine: Analgesic Adjunct in Adult Pectus Surgery. J Surg Res. 2023 Sep;289:171-181. doi: 10.1016/j.jss.2023.03.016. Epub 2023 Apr 28.

  PMID: 37121043 BACKGROUND

• Fidkowski CW, Choksi N, Alsaden MR. A randomized-controlled trial comparing liposomal bupivacaine, plain bupivacaine, and the mixture of liposomal bupivacaine and plain bupivacaine in transversus abdominus plane block for postoperative analgesia for open abdominal hysterectomies. Can J Anaesth. 2021 Jun;68(6):773-781. doi: 10.1007/s12630-020-01911-1. Epub 2021 Jan 11.

  PMID: 33432496 BACKGROUND

• Nguyen A, Grape S, Gobbetti M, Albrecht E. The postoperative analgesic efficacy of liposomal bupivacaine versus long-acting local anaesthetics for peripheral nerve and field blocks: A systematic review and meta-analysis, with trial sequential analysis. Eur J Anaesthesiol. 2023 Sep 1;40(9):624-635. doi: 10.1097/EJA.0000000000001833. Epub 2023 Apr 10.

  PMID: 37038770 BACKGROUND

• Kim DH, Liu J, Beathe JC, Lin Y, Wetmore DS, Kim SJ, Haskins SC, Garvin S, Oxendine JA, Ho MC, Allen AA, Popovic M, Gbaje E, Wu CL, Memtsoudis SG. Interscalene Brachial Plexus Block with Liposomal Bupivacaine versus Standard Bupivacaine with Perineural Dexamethasone: A Noninferiority Trial. Anesthesiology. 2022 Mar 1;136(3):434-447. doi: 10.1097/ALN.0000000000004111.

  PMID: 35041742 BACKGROUND

• Albrecht E, Vorobeichik L, Jacot-Guillarmod A, Fournier N, Abdallah FW. Dexamethasone Is Superior to Dexmedetomidine as a Perineural Adjunct for Supraclavicular Brachial Plexus Block: Systematic Review and Indirect Meta-analysis. Anesth Analg. 2019 Mar;128(3):543-554. doi: 10.1213/ANE.0000000000003860.

  PMID: 30303864 BACKGROUND

• Abdallah FW, Brull R. Facilitatory effects of perineural dexmedetomidine on neuraxial and peripheral nerve block: a systematic review and meta-analysis. Br J Anaesth. 2013 Jun;110(6):915-25. doi: 10.1093/bja/aet066. Epub 2013 Apr 15.

  PMID: 23587874 BACKGROUND

• Pehora C, Pearson AM, Kaushal A, Crawford MW, Johnston B. Dexamethasone as an adjuvant to peripheral nerve block. Cochrane Database Syst Rev. 2017 Nov 9;11(11):CD011770. doi: 10.1002/14651858.CD011770.pub2.

  PMID: 29121400 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

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 Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will not be able to see overhear from the block team the type of drugs used in the block.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Acute Pain Service Anesthesia Department, Principal Investigator, Clinical Professor

Model Details: single blinded randomized control trial.

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 12, 2024
• Study Start: October 15, 2024
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)