Utility of Exparel Based ESP Blocks in Elective Posterior Spine Fusion

Utility of Exparel Based Erector Spinae Plane Block for Elective 1 and 2 Level Posterior-based Lumbar Fusion: A Randomized Control Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia, Local; Spine Fusion
• Intervention / Treatment: Drug: Liposomal bupivacaine; Drug: Bupivacaine

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Heeren Makanji, MD; Phone Number: 860-549-8252; Email: Heeren.Makanji@hhchealth.org
• Study Contact Backup: Name: Matthew Solomito, PhD; Phone Number: 860-972-5656; Email: matthew.solomito@hhchealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Liposomal bupivacaine; Patients will receive either liposomal bupivacaine as part of the ESPB .; Other Names: Exparel
Active Comparator: 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.	Drug: Bupivacaine; This is the control group comparator as this is standard of care at the investigator's institution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Use	Opioid Use in patient stay measured in morphine milligram equivalents	72 hours (standard inpatient stay)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Report at Rest-Immediate postop	Pain as measured using Numeric Pain Scale (NPS) while patient is at rest immediate postoperative. The minimum value on the NPS is 0 indicating no pain (best outcome) and 10 indicates severe pain (worst outcome)	Asked immediately after surgery while patient is recovering in the post-anesthesia care unit (PACU).
Pain Report with activity-Immediate postop	Pain as measured using Numeric Pain Scale (NPS) while patient is active immediate postoperative. The minimum value on the NPS is 0 indicating no pain (best outcome) and 10 indicates severe pain (worst outcome)	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	Pain as measured using Numeric Pain Scale (NPS) while patient is at rest 24 hours after surgery. The minimum value on the NPS is 0 indicating no pain (best outcome) and 10 indicates severe pain (worst outcome).	24 hours post-op
Pain Report with activity-Post op day 1	Pain as measured using Numeric Pain Scale (NPS) with activity 24 hours after surgery. The minimum value on the NPS is 0 indicating no pain (best outcome) and 10 indicates severe pain (worst outcome).	24 hours post-op
Pain Report at rest-at discharge	Pain as measured using Numeric Pain Scale (NPS) while patient is at rest at discharge. The minimum value on the NPS is 0 indicating no pain (best outcome) and 10 indicates severe pain (worst outcome).	72 hours post-op
Pain Report with activity-at discharge	Pain as measured using Numeric Pain Scale (NPS) with activity at discharge. The minimum value on the NPS is 0 indicating no pain (best outcome) and 10 indicates severe pain (worst outcome).	72 hours post-op
PACU recovery time	Time from entry into PACU to time patient is listed as recovered	<5 hours post op
Patient Statisfcation	Based on Press Ganey Patient Satisfaction Survey. The minimum score is 0 (very poor) while the maximum score is 100 (very good).	10-14 days post-op
Patient reported outcomes score	Oswestry Disability Index (ODI) score. The minimum ODI score is 0 and represents minimal disability, while the maximum score of 100 represents the worst outcome - bed-bound significant disability.	3 months post-op

Collaborators and Investigators

• Sponsor: Hartford Hospital
• Investigators: Principal Investigator: Heeren Makanji, MD, Hartford HealthCare

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Erector Spinae Block; bupivacaine; Lumbar Spine; Exparel
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: HHC-2023-0204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared as part of this study.

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