Erector Spinae Plane Blocks (ESP) for Postoperative Pain in Lumbo-sacral Spine Surgery
Primary Purpose
Erector Spinae Plane Block, Lumbar Spine Surgery
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bilateral lumbar erector spinae plane block
Sponsored by
About this trial
This is an interventional treatment trial for Erector Spinae Plane Block
Eligibility Criteria
Inclusion Criteria:
- Spine surgery at or below the L1 vertebral level
- Midline surgical approach
Exclusion Criteria:
- Previous lumbar or lumbo-sacral surgery with or without hardware placement
- Evidence of dura pathology (including CSF leak)
- Spine tumor
- Non-English speaking
Sites / Locations
- University of California San FranciscoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Treatment group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Postoperative pain scores
Pain scores will be measured and documented as part of routine clinical care using the standard NRS (numerical rating scale, ranging from 0= no pain to 10= worst imaginable pain). Pain assessments will be made several times per day starting pre-operatively and continued during hospitalization.
Perioperative opiate consumption
Peri-operative opiate consumption will be assessed by measuring opiate administration intra- and post-operatively (during hospitalization) and expressed as oral morphine equivalents (OMEs).
Secondary Outcome Measures
Full Information
NCT ID
NCT04233736
First Posted
January 15, 2020
Last Updated
July 16, 2021
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT04233736
Brief Title
Erector Spinae Plane Blocks (ESP) for Postoperative Pain in Lumbo-sacral Spine Surgery
Official Title
Bilateral Erector Spinae Plane Blocks (ESP) for Postoperative Pain in Lumbo-sacral Spine Surgery: A Double-blinded Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to evaluate the analgesic efficacy of bilateral erector spinae plane (ESP) blocks after lumbar and lumbo-sacral spine surgery by assessing postoperative pain scores and opiate requirements as the primary outcome measures. We are aiming to investigate how ESP blocks, performed under ultrasound guidance at the T12 vertebral level, contribute to postoperative pain control. This will be determined by measuring numerical rating pain scores repeatedly following surgery and opiate consumption until patient discharge from hospital. These primary outcome measures will be compared between a treatment group of participants, who will receive ESP blocks and a control group who will receive a sham block. Our primary hypothesis is that ESP blocks significantly reduce postoperative pain and opiate requirements
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erector Spinae Plane Block, Lumbar Spine Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Active Comparator
Arm Title
Control group
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Bilateral lumbar erector spinae plane block
Intervention Description
Bilateral lumbar erector spinae plane blocks performed under ultrasound guidance
Primary Outcome Measure Information:
Title
Postoperative pain scores
Description
Pain scores will be measured and documented as part of routine clinical care using the standard NRS (numerical rating scale, ranging from 0= no pain to 10= worst imaginable pain). Pain assessments will be made several times per day starting pre-operatively and continued during hospitalization.
Time Frame
During hospitalization, typically lasting between 1 and 5 days
Title
Perioperative opiate consumption
Description
Peri-operative opiate consumption will be assessed by measuring opiate administration intra- and post-operatively (during hospitalization) and expressed as oral morphine equivalents (OMEs).
Time Frame
During hospitalization, typically lasting between 1 and 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Spine surgery at or below the L1 vertebral level
Midline surgical approach
Exclusion Criteria:
Previous lumbar or lumbo-sacral surgery with or without hardware placement
Evidence of dura pathology (including CSF leak)
Spine tumor
Non-English speaking
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claas Siegmueller, MD PhD MBA
Phone
415-443-0155
Email
siegmuellerc@anesthesia.ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claas Siegmueller, MD PhD MBA
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claas Siegmueller, MD PhD MBA
Phone
415-443-0155
Email
siegmuellerc@anesthesia.ucsf.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Erector Spinae Plane Blocks (ESP) for Postoperative Pain in Lumbo-sacral Spine Surgery
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