Erector Spinae Block for Spine Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Bupivacaine only bupivacaine 0.25% in ESP blocks |
Drug: Bupivacaine
bupivacaine 0.25% in ESP blocks
|
| Experimental: Liposomal Bupivacaine and Bupivacaine liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks |
Drug: Liposomal bupivacaine
liposomal bupivacaine
Drug: Bupivacaine
bupivacaine 0.25% in ESP blocks
|
Outcome Measures
Primary Outcome Measures
- Postoperative opioid consumption during first 72 hours [72 hours]
The amount of postoperative intravenous opioid consumption (Total morphine mg equivalents MME) during the first 72 hours
Secondary Outcome Measures
- Change in Pain score [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.
- Change in Quality of Recovery (QOR 15) [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.
- Postoperative nausea/vomiting (PONV) [in PACU (4 hours)]
Incidence (yes/no) of postoperative nausea/vomiting in PACU
- Time to ambulation [72 hours]
Time to ambulation in hours
- Hospital length of stay [72 hours]
Hospital length of stay (LOS)
Eligibility Criteria
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:
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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.
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Patients with a history of alcohol or drug abuse.
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Patients with a history of intolerance of nonsteroidal anti-inflammatory drugs.-Patients with hepatic insufficiency.
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Patients with renal insufficiency.
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Patients who are pregnant.
-
Patients with American Society of Anesthesiologists physical status of 4 or greater.
-
Patients on immunosuppressive therapy. Pregnant patients.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mount Sinai Hospital | New York | New York | United States | 10029 |
Sponsors and Collaborators
- Icahn School of Medicine at Mount Sinai
Investigators
- Principal Investigator: Christina Jeng, MD, Icahn School of Medicine at Mount Sinai
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY-22-00168