Utility of Exparel Based ESP Blocks in Elective Posterior Spine Fusion

NCT06107660 | Unknown Phase 4 FDA Drug

• 1 other identifier: HHC-2023-0204
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to compare two different medications used to reduce pain during lower back fusion surgery. The main questions this study aims to answer are:

1. 1.Can liposomal bupivacaine, when included in a regional anesthesia technique called the Erector Spinae Plane block (ESPB), reduce opioid use post-operatively compared to the standard medication typically used in an ESPB (bupivacaine with stabilizing agents)?
2. 2.Do patients report lower pain and better satisfaction with their surgery when they receive liposomal bupivacaine in the ESPB compared to those that receive the standard medication?

Conditions

Spine Fusion; Anesthesia, Local

Keywords

Erector Spinae Block; Lumbar Spine; bupivacaine; Exparel

Outcome Measures

Primary Outcomes (1)

• Opioid Use

  Opioid Use in patient stay measured in morphine milligram equivalents

  72 hours (standard inpatient stay)

Secondary Outcomes (9)

• Pain Report at Rest-Immediate postop

  Asked immediately after surgery while patient is recovering in the post-anesthesia care unit (PACU).

• Pain Report with activity-Immediate postop

  Patient is asked their pain level once they have been moved to their hospital room from the PACU. Typically this occurs within 5 hours of surgery.

• Pain Report at Rest-Post op day 1

  24 hours post-op

• Pain Report with activity-Post op day 1

  24 hours post-op

• Pain Report at rest-at discharge

  72 hours post-op

Study Arms (2)

Study Group

EXPERIMENTAL

Patients in the study Group will receive 20ml 1.3% Liposomal bupivacaine (Exparel®) dose of 266mg with 40 ml of 0.25% bupivacaine. The local anesthetic solution will be administered bilaterally in the plane between the lumber transverse process and the erector spinae muscles to block the dorsal and ventral rami of the spinal nerves under ultrasound guidance using a standard block needled. A total of 60 ml solution will be injected -30 ml on each side of the spinal column.

Drug: Liposomal bupivacaine

Control Group

ACTIVE COMPARATOR

Patients in the control group will receive 60ml of 0.25% bupivacaine with 5 mg preservative free dexamethasone and 150 mcg Epinephrine (in a 1:400,000 dilution). The local anesthetic solution will be administered bilaterally in the plane between the lumber transverse process and the erector spinae muscles to block the dorsal and ventral rami of the spinal nerves under ultrasound guidance using a standard block needled. A total of 60 ml solution will be injected -30 ml on each side of the spinal column.

Drug: Bupivacaine

Interventions

Liposomal bupivacaine DRUG

Patients will receive either liposomal bupivacaine as part of the ESPB .

Also known as: Exparel

Study Group

Bupivacaine DRUG

This is the control group comparator as this is standard of care at the investigator's institution.

Control Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lumbar pathology requiring a single or two level elective posterior based (i.e. posterior or transforaminal approach) spine fusion with or without an interbody device.
• Surgical approach through either a midline or paramedian incision
• Primary fusion surgery, previous decompression surgery is acceptable
• American Society of Anesthesiologists (ASA) score of 1,2,or 3.

You may not qualify if:

• Patients currently on narcotic pain medication for pain management
• Patients with a history of illicit drug use
• Patients with neuromuscular disorders or neurological deficits (i.e. post polio or myasthenia gravis)
• Patients confined to a wheelchair for over 6 months
• Patients with fibromyalgia or other chronic pain disorder
• Patient with contraindications for use of the ESP block (i.e. local skin infection over the area of needle entry, or anaphylactic reaction to bupivacaine)
• Non-invasive surgical approaches
• Repeat or revision surgery
• Non-posterior spine surgical approaches (i.e. lateral, oblique, anterior, anterior and posterior approaches)
• Staged procedures
• Adjacent segment surgery
• Patients with a weight less than 40kg to avoid local anesthetic systematic toxicity.

Sponsors & Collaborators

• Hartford Hospital: lead

Related Publications (1)

• Makanji HS, Solomito MJ, Maffeo-Mitchell C, Esmende S, Finkel K. Utility of Erector Spinae Plane Blocks for Postoperative Pain Management and Opioid Reduction Following Lumbar Fusions. Clin Spine Surg. 2023 May 1;36(4):E131-E134. doi: 10.1097/BSD.0000000000001387. Epub 2022 Sep 13.

  PMID: 36097343 BACKGROUND

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Heeren Makanji, MD

  Hartford HealthCare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heeren Makanji, MD

CONTACT

860-549-8252; Heeren.Makanji@hhchealth.org

Matthew Solomito, PhD

CONTACT

860-972-5656; matthew.solomito@hhchealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient, orthopedic surgeon (investigator or care provider), and outcome assessor performing data analysis will be blinded to this study. The regional anesthesia block is performed prior to surgical incision without the surgeon present, and thus the surgeon will be blinded to which formulation was provided. The patient will be informed that they are receiving a block but will not be informed until data collection is complete at the 3 month mark as to which group they were part of. Non-blinded Parties: Due to differences in the physical appearance it is impossible to blind the anesthesia team (attending and fellow) performing the block, as the standard block is clear while the Exparel formulation is milky. However, after the regional block has been performed the regional team will have no further contact with the patient as per standard practice, and thus maintaining a separation between those blinded and not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrolled participants will be randomized to receive either a mixture of liposomal bupivacaine/ bupivacaine or standard bupivacaine with adjuncts for their ESPB.

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 30, 2023
• Study Start: December 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share