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Clinical Trials/NCT04233736
NCT04233736
Unknown
Not Applicable

Bilateral Erector Spinae Plane Blocks (ESP) for Postoperative Pain in Lumbo-sacral Spine Surgery: A Double-blinded Randomized Controlled Trial

University of California, San Francisco1 site in 1 country160 target enrollmentJuly 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Erector Spinae Plane Block
Sponsor
University of California, San Francisco
Enrollment
160
Locations
1
Primary Endpoint
Perioperative opiate consumption
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
July 1, 2021
End Date
January 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Perioperative opiate consumption

Time Frame: During hospitalization, typically lasting between 1 and 5 days

Peri-operative opiate consumption will be assessed by measuring opiate administration intra- and post-operatively (during hospitalization) and expressed as oral morphine equivalents (OMEs).

Postoperative pain scores

Time Frame: During hospitalization, typically lasting between 1 and 5 days

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.

Study Sites (1)

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