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

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT04233736
Collaborator
(none)
160
Enrollment
1
Location
2
Arms
6
Anticipated Duration (Months)
26.5
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bilateral lumbar erector spinae plane block
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Bilateral Erector Spinae Plane Blocks (ESP) for Postoperative Pain in Lumbo-sacral Spine Surgery: A Double-blinded Randomized Controlled Trial
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Jan 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Treatment group

Procedure: Bilateral lumbar erector spinae plane block
Bilateral lumbar erector spinae plane blocks performed under ultrasound guidance
Sham Comparator: Control group

Procedure: Bilateral lumbar erector spinae plane block
Bilateral lumbar erector spinae plane blocks performed under ultrasound guidance

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California San Francisco San Francisco California United States 94143

Sponsors and Collaborators

  • University of California, San Francisco

Investigators

  • Principal Investigator: Claas Siegmueller, MD PhD MBA, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT04233736
Other Study ID Numbers:
  • 19-28625
First Posted:
Jan 18, 2020
Last Update Posted:
Jul 23, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pain, Postoperative

Study Results

No Results Posted as of Jul 23, 2021