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ESP Blocks for Posterior Spinal Fusion

NCT ID: NCT07228039

Last Updated: 2025-11-13

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

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-01-31

Brief Summary

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This prospective randomized double-blind study evaluates the efficacy of erector spinae plane (ESP) blocks on postoperative pain in patients undergoing cervical or lumbar posterior spinal fusion. Patients will receive either 0.5% bupivacaine plus liposomal bupivacaine or 0.5% plain bupivacaine. Outcomes include opioid consumption over 72 hours, pain scores, length of stay, and time to ambulation.

Detailed Description

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Conditions

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Postoperative Pain

Keywords

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ESP Block Spinal Fusion Multimodal Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ESP + Liposomal Bupivacaine

Group 1 receives ESP block with 0.5% bupivacaine plus liposomal bupivacaine.

Group Type EXPERIMENTAL

ESP Block with Bupivacaine + Liposomal Bupivacaine

Intervention Type DRUG

Cervical and lumbar ESP blocks performed under ultrasound guidance using bupivacaine admixed with liposomal bupivacaine.

ESP + Plain Bupivacaine

Group 2 receives ESP block with 0.5% plain bupivacaine.

Group Type EXPERIMENTAL

ESP Block with Bupivacaine

Intervention Type DRUG

Cervical and lumbar ESP blocks performed under ultrasound guidance using plain bupivacaine.

Interventions

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ESP Block with Bupivacaine + Liposomal Bupivacaine

Cervical and lumbar ESP blocks performed under ultrasound guidance using bupivacaine admixed with liposomal bupivacaine.

Intervention Type DRUG

ESP Block with Bupivacaine

Cervical and lumbar ESP blocks performed under ultrasound guidance using plain bupivacaine.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* English speaking
* Age 18-75
* ASA physical status 1-3
* Undergoing elective cervical or lumbar posterior spinal fusion (≤3 levels)

Exclusion Criteria

* Age \<18 or \>75
* ASA IV or V
* Non-English speaking
* BMI \>40
* Opioid dependence
* Chronic pain
* Anticoagulation or coagulopathy
* Injection site infection
* Hepatic or renal insufficiency
* Allergy to study drugs
* Pregnancy
* Inability to communicate with investigators
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Davies

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00118950

Identifier Type: -

Identifier Source: org_study_id