Recruiting
Phase 4

Bupivacaine with Liposomal Bupivacaine

Sponsor:

Duke University

Code:

NCT07228039

Conditions

Postoperative Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ESP Block with Bupivacaine

ESP Block with Bupivacaine + Liposomal Bupivacaine

Study Details

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

Study ID

NCT07228039

Start date

Sep 17, 2026

Status verified date

Nov, 2025

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ESP + Liposomal Bupivacaine

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

experimental: ESP + Plain Bupivacaine

Group 2 receives ESP block with 0.5% plain bupivacaine.

Interventions

ESP Block with Bupivacaine

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

ESP Block with Bupivacaine + Liposomal Bupivacaine

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

Primary outcome measure

  • Postoperative Pain as measured by opiate consumption [ Time Frame: 72 hours ]

Central Contacts and Locations

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Stephen Davies

(831) 359 -894stephen.c.davies@duke.edu

More Information

Sponsor

Duke University

Last update posted

Oct 26, 2026

Last verified

Nov, 2025

Keywords

  • ESP Block
  • Spinal Fusion
  • Multimodal Analgesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by Duke University on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.