Erector Spinae Block for Spine Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lumbar Radiculopathy

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine only<br>bupivacaine 0.25% in ESP blocks | Drug: Bupivacaine<br>* bupivacaine 0.25% in ESP blocks<br>|
| Experimental: Liposomal Bupivacaine and Bupivacaine<br>liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks | Drug: Liposomal bupivacaine<br>* liposomal bupivacaine<br>Drug: Bupivacaine<br>* bupivacaine 0.25% in ESP blocks<br>|

What is the study measuring?
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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 | 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 | 
| Change in 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. | up to 12 weeks | 
| Postoperative nausea/vomiting (PONV) | Incidence (yes/no) of postoperative nausea/vomiting in PACU | in PACU (4 hours) | 
| Time to ambulation | Time to ambulation in hours | 72 hours | 
| Hospital length of stay | Hospital length of stay (LOS) | 72 hours |