- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05417113
Erector Spinae Block for Spine Surgery
Evaluation of the Addition of Liposomal Bupivacaine to the Erector Spinae Plane (ESP) Block to Multilevel Lumbar Spinal Fusion Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Christina Jeng, MD
- Phone Number: 212-241-6426
- Email: christina.jeng@mountsinai.org
Study Contact Backup
- Name: Garrett Burnett, MD
- Phone Number: 212-241-6426
- Email: garrett.burnett@mountsinai.org
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Mount Sinai Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bupivacaine only
bupivacaine 0.25% in ESP blocks
|
bupivacaine 0.25% in ESP blocks
|
Experimental: Liposomal Bupivacaine and Bupivacaine
liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks
|
bupivacaine 0.25% in ESP blocks
liposomal bupivacaine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative opioid consumption during first 72 hours
Time Frame: 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
Time Frame: up to 12 weeks
|
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)
Time Frame: up to 12 weeks
|
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)
Time Frame: in PACU (4 hours)
|
Incidence (yes/no) of postoperative nausea/vomiting in PACU
|
in PACU (4 hours)
|
Time to ambulation
Time Frame: 72 hours
|
Time to ambulation in hours
|
72 hours
|
Hospital length of stay
Time Frame: 72 hours
|
Hospital length of stay (LOS)
|
72 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Christina Jeng, MD, Icahn School of Medicine at Mount Sinai
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY-22-00168
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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