Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04233736
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : July 23, 2021
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Erector Spinae Plane Block Lumbar Spine Surgery Procedure: Bilateral lumbar erector spinae plane block Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 1, 2021
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : January 1, 2022

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




Primary Outcome Measures :
  1. 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.

  2. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04233736


Contacts
Layout table for location contacts
Contact: Claas Siegmueller, MD PhD MBA 415-443-0155 siegmuellerc@anesthesia.ucsf.edu

Locations
Layout table for location information
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Claas Siegmueller, MD PhD MBA    415-443-0155    siegmuellerc@anesthesia.ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Claas Siegmueller, MD PhD MBA University of California, San Francisco
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04233736    
Other Study ID Numbers: 19-28625
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: July 23, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations