Video-assisted Thoracoscopic Surgery - Exparel Study

Last updated: February 19, 2025
Sponsor: Nada Sadek
Overall Status: Active - Not Recruiting

Phase

2

Condition

N/A

Treatment

Bupivacaine

Liposomal bupivacaine

Clinical Study ID

NCT04864210
201901777
  • Ages 18-80
  • All Genders

Study 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 (1). 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age over 18 years and less than 80 years

  • Undergoing video-assisted thoracoscopic surgery (VATS) procedure

  • BMI less than 40

Exclusion

Exclusion Criteria:

  • Unable to provide informed consent

  • Non-English speaking

  • Pregnant

  • BMI greater than 40

  • Video-assisted thoracoscopic surgery pleurodesis subjects

  • Patients with pre-existing chronic pain

  • Opioid tolerance

  • Pain syndromes including fibromyalgia, regional pain syndrome or post therapeuticneuralgia in a thoracic distribution

  • Allergy to the study medication

  • Patients with infectious disease

  • Patients with impaired coagulation

  • Severe hepatic disease

  • Incarcerated

Study Design

Total Participants: 176
Treatment Group(s): 2
Primary Treatment: Bupivacaine
Phase: 2
Study Start date:
February 02, 2021
Estimated Completion Date:
August 01, 2025

Study Description

The "promise" was that video-assisted thoracoscopic surgery (VATS) would be associated with less severe pulmonary impairment and less acute post-operative pain compared to open thoracotomy. However, VATS can cause moderate to severe post-operative pain in a significant number of patients and the reason for this is not well understood. In addition it has been found that post-surgical pain can be a strong predictor for the development of chronic pain. Inadequate control of acute pain not only causes serious discomfort and significant respiratory problems, but it may place this population of patients at greater risk of chronic pain and prescription opioid dependence.

Current protocols to manage and/or reduce VATS associated pain include combining the use of regional anesthesia techniques with opioid and non-opioid analgesics. Recent studies have investigated the efficacy of intercostal blocks using liposomal bupivacaine after thoracic surgery. However, these studies lacked an active comparator population of patients.

The study is designed as a prospective randomized study evaluating intercostal blocks using liposomal bupivacaine. The control population of patients will be treated with a paravertebral block using plain bupivacaine.

Connect with a study center

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

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