Utility of Exparel Based ESP Blocks in Elective Posterior Spine Fusion

NCT ID: NCT06107660

Last Updated: 2023-10-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2025-12-31

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. 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. 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?

Participants will be randomized to into two groups one that receives liposomal bupivacaine and one group that receives bupivacaine with stabilizing agents. Other than the randomization all patients will follow current standard of care at our hospital, and will not be asked to complete any additional study forms in addition to forms currently asked of all patients as per standard of care.

Detailed Description

The purpose of this study is to improve pain management for patients having spine fusion surgery. This aim will be achieved by evaluating how well liposomal bupivacaine (LB), an FDA approved numbing medication that can provide pain relief for up to 72 hours after surgery, works when used as a single dose in a regional block known as Erector Spinae Plane block (ESPB). ESPB is a regional anesthesia technique used to control pain after surgery by injecting numbing medication around the patient's back bones on both sides. The study will compare how well LB in ESPB works compared to the standard practice procedure, which involves administering the traditional numbing medication (bupivacaine) through the ESPB. These two medications will be evaluated in reducing postoperative opioid medication need to control postoperative pain, as the primary goal. This study seeks to understand whether an ESP block either with bupivacaine and stabilizing agents or using liposomal bupivacaine, reduces the total amount of opioid medication used postoperatively, reduces pain scores, and leads to better patient reported outcome scores, patient satisfaction, and reduced recovery time in the PACU. Should the investigator find that liposomal bupivacaine is not superior to bupivacaine with stabilizing agents, this information would prove useful in regards to analgesic options for this patient population and could lead to a substantial cost savings.

Conditions

Spine Fusion; Anesthesia, Local

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Study Group

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.

Group Type: EXPERIMENTAL

Liposomal bupivacaine

Intervention Type: DRUG

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

Control Group

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.

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

Interventions

Liposomal bupivacaine

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

Intervention Type: DRUG

Bupivacaine

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

Intervention Type: DRUG

Other Intervention Names

Exparel

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hartford Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heeren Makanji, MD

Role: PRINCIPAL_INVESTIGATOR

Hartford HealthCare

Central Contacts

Heeren Makanji, MD

Role: CONTACT

Heeren.Makanji@hhchealth.org

860-549-8252

Matthew Solomito, PhD

Role: CONTACT

matthew.solomito@hhchealth.org

860-972-5656

References

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.

Reference Type: BACKGROUND

PMID: 36097343 (View on PubMed)

Other Identifiers

HHC-2023-0204

Identifier Type: -

Identifier Source: org_study_id