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NCT Number: NCT04864210

Video-assisted Thoracoscopic Surgery - Exparel Study

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age over 18 years and less than 80 years
  • Undergoing video-assisted thoracoscopic surgery (VATS) procedure
  • BMI less than 40

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 therapeutic neuralgia in a thoracic distribution
  • Allergy to the study medication
  • Patients with infectious disease
  • Patients with impaired coagulation
  • Severe hepatic disease
  • Incarcerated

Treatment and study plan

Liposomal bupivacaine

Drug

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.

Bupivacaine

Drug

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

Primary outcomes

  1. Number of Subjects With Post-operative Opioid Usage

    Time frame: Up to 48 hours post procedure

    The number of subjects who utilized opioid medications in the first 48 hours after surgery

Secondary outcomes

  1. Measure Lung Function

    Time frame: Up to 24 hours post procedure

    Using an incentive spirometer device, the amount of air volume inhaled and exhaled by the lungs post VATS procedure. The subject will be asked to do 3 attempts in succession and the number recorded will be the average of the 3 attempts. The air volume inhaled is measured on a scale from near 0 to 2500 milliliters with the low number indicating little air movement whereas 2500 milliliters indicates good air flow. These results will be compared to the volume determined at baseline prior to surgery.

  2. Measure Post-operative Opioid Consumption Following Discharge From the Hospital

    Time frame: Up to 6 months post procedure.

    Patients will be asked to keep a pain medication diary to record their use of opioid and non-opioid medications for pain control.

  3. Post-operative Numerical Rating Scores After Discharge From the Hospital

    Time frame: Up to 6 months post procedure.

    Using a numerical rating scale, patients will be asked to report their pain level. The scale is from 0 to 10 with 0 being no pain and 10 representing the most intense pain. The goal for measuring after acute hospitalization is to determine if the patient is experiencing the onset of chronic pain.

  4. Post-operative Acute Pain Numerical Rating Scores

    Time frame: Up to 24 hours post procedure

    Using a numerical rating scale (0-10), patients will be asked to report their pain level. The scale is from 0 to 10 with 0 being no pain and 10 representing the most intense pain.

Sponsors and collaborators

Lead sponsor

Nada Sadek

Other

Collaborators

  • American Society of Regional Anesthesia

Registry information

Official study title

Analgesia for Video-assisted Thoracoscopic Surgeries: A Comparison Between Intercostal Blocks With Liposomal Bupivacaine and Paravertebral Blocks With Plain Bupivacaine

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Apr 28, 2021
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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