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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04233736
Other study ID # 19-28625
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
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