Menu
Not yet recruiting NCT07228039

ESP Blocks for Posterior Spinal Fusion

Phase IV Interventional Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ESP Block with Bupivacaine, ESP Block with Bupivacaine + Liposomal Bupivacaine.
Who it may be relevant to
Registry conditions: Postoperative Pain. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug ESP Block with Bupivacaine
    Cervical and lumbar ESP blocks performed under ultrasound guidance using plain bupivacaine.
  • Drug ESP Block with Bupivacaine + Liposomal Bupivacaine
    Cervical and lumbar ESP blocks performed under ultrasound guidance using bupivacaine admixed with liposomal bupivacaine.

Primary outcome measures

  • Postoperative Pain as measured by opiate consumption [Time frame: 72 hours]
Secondary outcome measures (5)
  • Postoperative Pain at rest and with movement as measured by patient reported pain scores [Time frame: 4, 8, 12, 24, 48, and 72 hours]
  • Discharge Readiness [Time frame: 72 hours]
  • Postoperative Pain Severity as measured by required time for patient controlled-analgesia [Time frame: 72 hours]
  • Incidents of post-operative nausea and vomiting [Time frame: 72 hours]
  • Time to first ambulation [Time frame: 72 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Duke University — Durham

Identifiers

NCT: NCT07228039 · Pro00118950

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗