Erector Spinae Block for Spine Surgery

Phase 4TerminatedNCT05417113

Icahn School of Medicine at Mount Sinai13 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Lumbar Radiculopathy

Interventions

Liposomal bupivacaineDRUG

liposomal bupivacaine

BupivacaineDRUG

bupivacaine 0.25% in ESP blocks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mount Sinai Hospital

New York, New York, United States

Outcomes

Primary Outcomes

Postoperative Opioid Consumption During First 72 Hours

The amount of postoperative intravenous opioid consumption (Total morphine mg equivalents MME) during the first 72 hours

Time frame: 12 hours, 24 hours, 48 hours, 72 hours

Secondary Outcomes

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.

Time frame: 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.

Time frame: 72 hours

Number of Participants With Postoperative Nausea/Vomiting (PONV)

Number of participants with postoperative nausea/vomiting (PONV) in PACU

Time frame: in PACU (4 hours)

Time to Ambulation

Time to ambulation in hours

Time frame: average 26-27 hours

Hospital Length of Stay

Hospital length of stay (LOS)

Time frame: average 72 hours

Data from ClinicalTrials.gov

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