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

NCT ID: NCT04233736

Last Updated: 2021-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-01-01

Brief Summary

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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

Detailed Description

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Conditions

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Erector Spinae Plane Block Lumbar Spine Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Treatment group

Group Type ACTIVE_COMPARATOR

Bilateral lumbar erector spinae plane block

Intervention Type PROCEDURE

Bilateral lumbar erector spinae plane blocks performed under ultrasound guidance

Control group

Group Type SHAM_COMPARATOR

Bilateral lumbar erector spinae plane block

Intervention Type PROCEDURE

Bilateral lumbar erector spinae plane blocks performed under ultrasound guidance

Interventions

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Bilateral lumbar erector spinae plane block

Bilateral lumbar erector spinae plane blocks performed under ultrasound guidance

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claas Siegmueller, MD PhD MBA

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Claas Siegmueller, MD PhD MBA

Role: CONTACT

415-443-0155

Facility Contacts

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Claas Siegmueller, MD PhD MBA

Role: primary

415-443-0155

Other Identifiers

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19-28625

Identifier Type: -

Identifier Source: org_study_id

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