Clinical trial NCT05417113: Erector Spinae Block for Spine Surgery
Official title: Evaluation of the Addition of Liposomal Bupivacaine to the Erector Spinae Plane (ESP) Block to Multilevel Lumbar Spinal Fusion Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Lumbar Radiculopathy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative Opioid Consumption During First 72 Hours
timeFrame: 12 hours, 24 hours, 48 hours, 72 hours
Secondary outcomes:
measure: Change in Pain Score
timeFrame: up to 12 weeks
measure: Quality of Recovery (QOR 15)
timeFrame: 72 hours
measure: Number of Participants With Postoperative Nausea/Vomiting (PONV)
timeFrame: in PACU (4 hours)
measure: Time to Ambulation
timeFrame: average 26-27 hours
measure: Hospital Length of Stay
timeFrame: average 72 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Christina Jeng, MD
role: PRINCIPAL_INVESTIGATOR
References: