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ESP Blocks for Posterior Spinal Fusion

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07228039
Enrollment
75
Registered
2025-11-13
Start date
2027-10-01
Completion date
2028-01-01
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

ESP Block, Spinal Fusion, Multimodal Analgesia

Brief summary

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

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

DRUGESP Block with Bupivacaine + Liposomal Bupivacaine

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

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain as measured by opiate consumption72 hoursMorphine MilliEquivalents

Secondary

MeasureTime frameDescription
Postoperative Pain at rest and with movement as measured by patient reported pain scores4, 8, 12, 24, 48, and 72 hoursNumeric Rating Scale (0-10) 0 being no pain, 10 being worst pain imaginable
Discharge Readiness72 hoursHospital and PACU Length of Stay
Postoperative Pain Severity as measured by required time for patient controlled-analgesia72 hoursDuration of patient controlled analgesia use
Incidents of post-operative nausea and vomiting72 hoursPost-operative Nausea and Vomiting
Time to first ambulation72 hours

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORStephen Davies

Duke University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026