Erector Spinae Block for Spine Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2024-02-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Utility of Exparel Based ESP Blocks in Elective Posterior Spine Fusion

NCT06107660

Spine Fusion Anesthesia, Local

NOT_YET_RECRUITING PHASE4

Liposomal Bupivacaine for Pain After Lumbar Fusion

NCT07171125

Postoperative Acute Pain Lumbar Degenerative Diseases

RECRUITING PHASE4

Effects of Continuous ESP Catheters on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery

NCT05494125

Post Operative Pain Spine Surgery

TERMINATED NA

Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery

NCT04156581

Opioid Use Pain, Postoperative

COMPLETED PHASE4

Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion

NCT03745040

Lumbar Spinal Stenosis Lumbar Disc Herniation Lumbar Disc Disease +1 more

SUSPENDED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lumbar Radiculopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bupivacaine only

bupivacaine 0.25% in ESP blocks

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

bupivacaine 0.25% in ESP blocks

Liposomal Bupivacaine and Bupivacaine

liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks

Group Type EXPERIMENTAL

Liposomal bupivacaine

Intervention Type DRUG

liposomal bupivacaine

Bupivacaine

Intervention Type DRUG

bupivacaine 0.25% in ESP blocks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Liposomal bupivacaine

liposomal bupivacaine

Intervention Type DRUG

Bupivacaine

bupivacaine 0.25% in ESP blocks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No