Erector Spinae Plane Blocks (ESP) for Postoperative Pain in Lumbo-sacral Spine Surgery

Not Applicable

• Conditions: Erector Spinae Plane Block; Lumbar Spine Surgery
• Interventions: Procedure: Bilateral lumbar erector spinae plane block

• Registration Number: NCT04233736
• Lead Sponsor: University of California, San Francisco

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Status Verified: 2021-07
• Study Start: 2021-07-01
• Last Update Submitted: 2021-07-16
• Last Update Posted: 2021-07-23
• Primary Completion: 2021-11-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Spine surgery at or below the L1 vertebral level
• Midline surgical approach

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Bilateral lumbar erector spinae plane block	-
Treatment group	Bilateral lumbar erector spinae plane block	-

Primary Outcome Measures

Name	Time	Method
Perioperative opiate consumption	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	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.

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States