ESP Blocks for Posterior Spinal Fusion

Duke University

Status and phase: Not yet enrolling; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: ESP Block with Bupivacaine + Liposomal Bupivacaine; Drug: ESP Block with Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT07228039

Pro00118950

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 2 patient groups

ESP + Liposomal Bupivacaine

Experimental group

Description:

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

Treatment:

Drug: ESP Block with Bupivacaine + Liposomal Bupivacaine

ESP + Plain Bupivacaine

Experimental group

Description:

Group 2 receives ESP block with 0.5% plain bupivacaine.

Treatment:

Drug: ESP Block with Bupivacaine