NCT06810375

Brief Summary

This clinical trial compares efficacy in postoperative pain management in thoracic surgery between erector spinae block versus liposomal bupivacaine injections.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
35mo left

Started Mar 2025

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Mar 2025Feb 2029

First Submitted

Initial submission to the registry

January 24, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

January 24, 2025

Last Update Submit

April 6, 2026

Conditions

Lung Cancers

Outcome Measures

Primary Outcomes (2)

  • Postoperative pain control assessment

    Study team will assess postoperative pain scores at 6, 12, 24 and 48 hours (Minimum numerical pain score of 0 and a maximum of 10)

    Up to 48 hours postoperatively

  • Morphine equivalent assessment

    Study team will collect information on all administered pain medications to calculate morphine equivalents

    Up to 72 hours postoperatively

Secondary Outcomes (1)

  • Postoperative pain control assessment

    Up to 72 hours postoperatively

Study Arms (2)

Preoperative Erector Spinae Block (ESB)(Bupivacaine)(Marcaine®)

ACTIVE COMPARATOR
Drug: Erector Spinae (ESP) Block with Bupivacaine (Marcaine®)Drug: Intercostal nerve block

Intraoperative Intercostal Nerve Block (INB)(Liposomal Bupivacaine)(Exparel®)

ACTIVE COMPARATOR
Drug: Erector Spinae (ESP) Block with Bupivacaine (Marcaine®)Drug: Intercostal nerve block

Interventions

Erector Spinae (ESP) Block with Bupivacaine (Marcaine®)DRUG

preoperative erector spinae block with bupivacaine (Marcaine®)

Intraoperative Intercostal Nerve Block (INB)(Liposomal Bupivacaine)(Exparel®)Preoperative Erector Spinae Block (ESB)(Bupivacaine)(Marcaine®)
Intercostal nerve blockDRUG

intraoperative intercostal nerve block with liposomal bupivacaine (Exparel®)

Intraoperative Intercostal Nerve Block (INB)(Liposomal Bupivacaine)(Exparel®)Preoperative Erector Spinae Block (ESB)(Bupivacaine)(Marcaine®)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Video assisted pulmonary resection, pleurodesis or decortication

You may not qualify if:

  • Allergy to local anesthetics
  • Patient undergoing bilateral surgery
  • Surgery is emergent as deemed by the principal investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

ParapsychologyDental OcclusionBupivacaine

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Behavioral SciencesBehavioral Disciplines and ActivitiesDentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Eduard Shaykhinurov, MS

CONTACT

2022038960eshaykhinurov@mfa.gwu.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal Investigator

Study Record Dates

First Submitted

January 24, 2025

First Posted

February 5, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

February 28, 2029

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)