ESP Blocks for Posterior Spinal Fusion

May 7, 2026 updated by: Duke University

A Double-Blind Prospective RCT Assessment of ESP Blocks for Analgesia Following Posterior Spinal Fusion

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESP + Liposomal Bupivacaine
Group 1 receives ESP block with 0.5% bupivacaine plus liposomal bupivacaine.
Drug: ESP Block with Bupivacaine + Liposomal Bupivacaine
Cervical and lumbar ESP blocks performed under ultrasound guidance using bupivacaine admixed with liposomal bupivacaine.
Experimental: ESP + Plain Bupivacaine
Group 2 receives ESP block with 0.5% plain bupivacaine.
Drug: ESP Block with Bupivacaine
Cervical and lumbar ESP blocks performed under ultrasound guidance using plain bupivacaine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain as measured by opiate consumption
Time Frame: 72 hours
Morphine MilliEquivalents
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discharge Readiness
Time Frame: 72 hours
Hospital and PACU Length of Stay
72 hours
Postoperative Pain Severity as measured by required time for patient controlled-analgesia
Time Frame: 72 hours
Duration of patient controlled analgesia use
72 hours
Incidents of post-operative nausea and vomiting
Time Frame: 72 hours
Post-operative Nausea and Vomiting
72 hours
Time to first ambulation
Time Frame: 72 hours
72 hours
Postoperative Pain at rest and with movement as measured by patient reported pain scores
Time Frame: 4, 8, 12, 24, 48, and 72 hours
Numeric Rating Scale (0-10) 0 being no pain, 10 being worst pain imaginable
4, 8, 12, 24, 48, and 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Stephen Davies, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

November 12, 2025

First Submitted That Met QC Criteria

November 12, 2025

First Posted (Actual)

November 13, 2025

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00118950

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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