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

Erector Spinae Plane Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04233736
• Other study ID #: 19-28625
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: July 2021
• Source: University of California, San Francisco
• Contact: Claas Siegmueller, MD PhD MBA
• Phone: 415-443-0155
• Email: siegmuellerc[@]anesthesia.ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erector Spinae Plane Block
• Lumbar Spine Surgery
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain scores	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
Primary	Perioperative opiate consumption	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