Erector Spinae Block for Spine Surgery

Evaluation of the Addition of Liposomal Bupivacaine to the Erector Spinae Plane (ESP) Block to Multilevel Lumbar Spinal Fusion Surgery

This study is to determine whether or not the addition of liposomal bupivacaine in an ESP block will have long term benefits for patients undergoing lumbar spinal fusion surgery. Given previous studies found long term benefits from liposomal bupivacaine, the hypothesis is that patients will have decreased opioid usage and improved pain scores when compared to a standard ESP block with plain 0.25% bupivacaine.

Study Overview

• Status: Terminated
• Conditions: Lumbar Radiculopathy
• Intervention / Treatment: Drug: Bupivacaine; Drug: Liposomal bupivacaine

Detailed Description

This will be a double blind prospective randomized control trial comparing liposomal bupivacaine with plain bupivacaine in their effectiveness in ESP blocks in lumbar spinal fusion surgery. Patients scheduled for a lumbar spinal fusion procedure will be identified at the time of the scheduled surgery. The endpoints of this study include:

The primary objective is to compare the amount of postoperative intravenous opioid consumption among two study groups for the first 72 hours: Patients undergoing posterior lumbar spinal fusion surgery (1-2 levels) under general anesthesia and ESP block with liposomal bupivacaine + 0.25% bupivacaine and patients undergoing posterior lumbar spinal fusion surgery (1-2 levels) under general anesthesia and ESP block with 0.25% bupivacaine

The secondary objectives include:

Compare the severity of pain at rest at specific timepoints postoperatively. Compare general quality of recovery via QoR-15 at 48 hours, 72 hours and then at routine follow up visits occurring 2 weeks, 6 weeks, and 12 weeks postoperatively.

Measure rate of postoperative nausea/vomiting in PACU. Measure time to ambulation. Compare analgesia satisfaction score at time of discharge. Measure hospital length of stay.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Adults aged greater than or equal to 18 years old and less than or equal to 85 years old.
• Patients who are scheduled to undergo lumbar spinal surgery (1-2 level) and willing and able to provide informed consent.

Exclusion criteria:

• Patients with a history of chronic opioid use for > 3 months including but not limited to fentanyl, morphine, oxycodone, methadone.
• Patients with known allergy or intolerance to any drug used in the study including local anesthetics and total intravenous anesthesia medications.
• Patients with a history of alcohol or drug abuse.
• Patients with a history of intolerance of nonsteroidal anti-inflammatory drugs.-Patients with hepatic insufficiency.
• Patients with renal insufficiency.
• Patients who are pregnant.
• Patients with American Society of Anesthesiologists physical status of 4 or greater.
• Patients on immunosuppressive therapy. Pregnant patients.

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
Active Comparator: Bupivacaine only; bupivacaine 0.25% in ESP blocks	Drug: Bupivacaine; bupivacaine 0.25% in ESP blocks
Experimental: Liposomal Bupivacaine and Bupivacaine; liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks	Drug: Bupivacaine; bupivacaine 0.25% in ESP blocks; Drug: Liposomal bupivacaine; liposomal bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Opioid Consumption During First 72 Hours	The amount of postoperative intravenous opioid consumption (Total morphine mg equivalents MME) during the first 72 hours	12 hours, 24 hours, 48 hours, 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Score	Change in the severity of pain at rest using an 11-point Likert scale. Scale from 0-10, with higher score indicating more pain.	up to 12 weeks
Quality of Recovery (QOR 15)	Change in general quality of recovery using a 15 point questionnaire via QoR-15 with regard to how the patient is feeling scored on a scale from 0-10, with 0 being none of the time and 10 being all of the time. Full scale range from 0-150, with a higher score indicating a better health outcome.	72 hours
Number of Participants With Postoperative Nausea/Vomiting (PONV)	Number of participants with postoperative nausea/vomiting (PONV) in PACU	in PACU (4 hours)
Time to Ambulation	Time to ambulation in hours	average 26-27 hours
Hospital Length of Stay	Hospital length of stay (LOS)	average 72 hours

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Christina Jeng, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2022
• Primary Completion (Actual): February 27, 2024
• Study Completion (Actual): February 27, 2024

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: STUDY-22-00168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IRB approval was not obtained to share IPD.

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.: No