Video-assisted Thoracoscopic Surgery - Exparel Study

April 15, 2026 updated by: Nada Sadek

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liposomal bupivacaine
The patient will receive an intercostal nerve block by the surgeon in the operating room after anesthetic has been administered. The surgeon will use thoracoscopic guidance to administer the intercostal nerve block. The medication used in this block will liposomal bupivacaine (Exparel).
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.
Active Comparator: Bupivacaine
The patient will receive a paravertebral block by the anesthesiologist staffing the pain service area within the hospital prior to surgery. This regional anesthesia will be done using ultrasound guidance. The medication used in this block will be plain bupivacaine with epinephrine.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 48 hours post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 24 hours post procedure
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.
Up to 6 months post procedure.
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.
Up to 6 months post procedure.
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.
Up to 24 hours post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nada Sadek

Collaborators

American Society of Regional Anesthesia

Investigators

  • Principal Investigator: Nada Sadek, MD, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2021

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

January 30, 2025

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

April 27, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201901777

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data (IPD) collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.

IPD Sharing Time Frame

IPD will be available for sharing immediately after publication and ending 5 years following article publication.

IPD Sharing Access Criteria

IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Postoperative

Clinical Trials on Liposomal bupivacaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe