Erector Spinae Plane Block Clinical Trial
Official title:
Bilateral Erector Spinae Plane Blocks (ESP) for Postoperative Pain in Lumbo-sacral Spine Surgery: A Double-blinded Randomized Controlled Trial
NCT number | NCT04233736 |
Other study ID # | 19-28625 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2021 |
Est. completion date | January 1, 2022 |
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
Status | Recruiting |
Enrollment | 160 |
Est. completion date | January 1, 2022 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | During hospitalization, typically lasting between 1 and 5 days | |
Primary | 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). | During hospitalization, typically lasting between 1 and 5 days |
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