Status:
TERMINATED
Erector Spinae Block for Spine Surgery
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Lumbar Radiculopathy
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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 studie...
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 s...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2024
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05417113
Start Date
August 31 2022
End Date
February 27 2024
Last Update
May 29 2024
Active Locations (1)
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1
Mount Sinai Hospital
New York, New York, United States, 10029