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

NCT04233736 | Unknown

• 1 other identifier: 19-28625
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Erector Spinae Plane Block; Lumbar Spine Surgery

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

Procedure: Bilateral lumbar erector spinae plane block

Control group

SHAM COMPARATOR

Procedure: Bilateral lumbar erector spinae plane block

Interventions

Bilateral lumbar erector spinae plane block PROCEDURE

Bilateral lumbar erector spinae plane blocks performed under ultrasound guidance

Control group; Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous lumbar or lumbo-sacral surgery with or without hardware placement
• Evidence of dura pathology (including CSF leak)
• Spine tumor
• Non-English speaking

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Study Officials

• Claas Siegmueller, MD PhD MBA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claas Siegmueller, MD PhD MBA

CONTACT

415-443-0155; siegmuellerc@anesthesia.ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: July 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: January 1, 2022
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)