Erector Spinae Block for Spine Surgery
Primary Purpose
Lumbar Radiculopathy
Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
Bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Radiculopathy
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.
Sites / Locations
- Mount Sinai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Bupivacaine only
Liposomal Bupivacaine and Bupivacaine
Arm Description
bupivacaine 0.25% in ESP blocks
liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks
Outcomes
Primary Outcome Measures
Postoperative opioid consumption during first 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
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)
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)
Incidence (yes/no) of postoperative nausea/vomiting in PACU
Time to ambulation
Time to ambulation in hours
Hospital length of stay
Hospital length of stay (LOS)
Full Information
NCT ID
NCT05417113
First Posted
June 9, 2022
Last Updated
May 2, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT05417113
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 31, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine only
Arm Type
Active Comparator
Arm Description
bupivacaine 0.25% in ESP blocks
Arm Title
Liposomal Bupivacaine and Bupivacaine
Arm Type
Experimental
Arm Description
liposomal bupivacaine in addition to 0.25% bupivacaine in ESP blocks
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Intervention Description
liposomal bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
bupivacaine 0.25% in ESP blocks
Primary Outcome Measure Information:
Title
Postoperative opioid consumption during first 72 hours
Description
The amount of postoperative intravenous opioid consumption (Total morphine mg equivalents MME) during the first 72 hours
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Change in Pain score
Description
Change in the severity of pain at rest using an 11-point Likert scale. Scale from 0-10, with higher score indicating more pain.
Time Frame
up to 12 weeks
Title
Change in Quality of Recovery (QOR 15)
Description
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.
Time Frame
up to 12 weeks
Title
Postoperative nausea/vomiting (PONV)
Description
Incidence (yes/no) of postoperative nausea/vomiting in PACU
Time Frame
in PACU (4 hours)
Title
Time to ambulation
Description
Time to ambulation in hours
Time Frame
72 hours
Title
Hospital length of stay
Description
Hospital length of stay (LOS)
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Jeng, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IRB approval was not obtained to share IPD.
Learn more about this trial
Erector Spinae Block for Spine Surgery
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