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

July 16, 2021 updated by: University of California, San Francisco

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control group
Procedure: Bilateral lumbar erector spinae plane block
Bilateral lumbar erector spinae plane blocks performed under ultrasound guidance
Active Comparator: Treatment group
Procedure: Bilateral lumbar erector spinae plane block
Bilateral lumbar erector spinae plane blocks performed under ultrasound guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During hospitalization, typically lasting between 1 and 5 days
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).
During hospitalization, typically lasting between 1 and 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

January 15, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 16, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-28625

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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