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Video-assisted Thoracoscopic Surgery - Exparel Study

NCT04864210 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2026-05-06

Study results available
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Summary

Video-assisted thoracoscopic surgery (VATS) greatly decreased the number and types of surgery that required open thoracotomy. Initially it was thought that VATS would lead to a reduction of respiratory problems and less acute pain in patients when compared to patients receiving an open thoracic surgery. However, for reasons not clearly understood, a large number of patients who undergo VATS still experience moderate to severe post-surgical pain. Physicians are still faced with the challenge of providing care that will manage both the respiratory issues as well as manage acute pain. The goal of this study is to find the most suitable regimen to effectively manage post-VATS-related pain.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Liposomal bupivacaine

Surgeons will perform an intercostal nerve block in the operating room under thoracoscopic guidance while the patient is asleep under anesthesia. This intervention (block) is one of the standards of care but the medication (liposomal bupivacaine) currently is not FDA approved for this type of block.

DRUG

Bupivacaine

An anesthesiologist trained in regional anesthesia will perform a paravertebral block in the hospital's pain service unit. This intervention is standard of care and will use plain bupivacaine with epinephrine as the medication

Sponsors & Collaborators

  • American Society of Regional Anesthesia

    collaborator OTHER

  • Nada Sadek

    lead OTHER

Principal Investigators

  • Nada Sadek, MD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-02
Primary Completion
2024-08-01
Completion
2025-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04864210 on ClinicalTrials.gov