Erector Spinae Block for Spine Surgery

Mount Sinai Health System

Status and phase: Terminated; Phase 4

Conditions: Lumbar Radiculopathy

Treatments: Drug: Liposomal bupivacaine; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05417113

STUDY-22-00168

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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13 participants in 2 patient groups

Bupivacaine only

Active Comparator group

Description:

bupivacaine 0.25% in ESP blocks

Treatment:

Drug: Bupivacaine

Liposomal Bupivacaine and Bupivacaine

Experimental group

Description:

liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks

Treatment:

Drug: Bupivacaine

Drug: Liposomal bupivacaine