ESP Blocks for Posterior Spinal Fusion

NCT07228039 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: Pro00118950
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

ESP Block; Spinal Fusion; Multimodal Analgesia

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain as measured by opiate consumption

  Morphine MilliEquivalents

  72 hours

Secondary Outcomes (5)

• Postoperative Pain at rest and with movement as measured by patient reported pain scores

  4, 8, 12, 24, 48, and 72 hours

• Discharge Readiness

  72 hours

• Postoperative Pain Severity as measured by required time for patient controlled-analgesia

  72 hours

• Incidents of post-operative nausea and vomiting

  72 hours

• Time to first ambulation

  72 hours

Study Arms (2)

ESP + Liposomal Bupivacaine

EXPERIMENTAL

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

Drug: ESP Block with Bupivacaine + Liposomal Bupivacaine

ESP + Plain Bupivacaine

EXPERIMENTAL

Group 2 receives ESP block with 0.5% plain bupivacaine.

Drug: ESP Block with Bupivacaine

Interventions

ESP Block with Bupivacaine DRUG

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

ESP + Plain Bupivacaine

ESP Block with Bupivacaine + Liposomal Bupivacaine DRUG

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

ESP + Liposomal Bupivacaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Stephen Davies

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2025
• First Posted: November 13, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)