Video-assisted Thoracoscopic Surgery - Exparel Study

NCT04864210 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 201901777
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Video-assisted thoracoscopic surgery (VATS); Paravertebral blocks; Liposomal Bupivacaine (Exparel)

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Post-operative Opioid Usage

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

  Up to 48 hours post procedure

Secondary Outcomes (4)

• Measure Lung Function

  Up to 24 hours post procedure

• Measure Post-operative Opioid Consumption Following Discharge From the Hospital

  Up to 6 months post procedure.

• Post-operative Numerical Rating Scores After Discharge From the Hospital

  Up to 6 months post procedure.

• Post-operative Acute Pain Numerical Rating Scores

  Up to 24 hours post procedure

Study Arms (2)

Liposomal bupivacaine

EXPERIMENTAL

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

Bupivacaine

ACTIVE COMPARATOR

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

Interventions

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.

Liposomal bupivacaine

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

Bupivacaine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nada Sadek: lead
• American Society of Regional Anesthesia: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (10)

• Bayman EO, Parekh KR, Keech J, Larson N, Vander Weg M, Brennan TJ. Preoperative Patient Expectations of Postoperative Pain Are Associated with Moderate to Severe Acute Pain After VATS. Pain Med. 2019 Mar 1;20(3):543-554. doi: 10.1093/pm/pny096.

  PMID: 29878248 BACKGROUND

• Bayman EO, Parekh KR, Keech J, Selte A, Brennan TJ. A Prospective Study of Chronic Pain after Thoracic Surgery. Anesthesiology. 2017 May;126(5):938-951. doi: 10.1097/ALN.0000000000001576.

  PMID: 28248713 BACKGROUND

• Furrer M, Rechsteiner R, Eigenmann V, Signer C, Althaus U, Ris HB. Thoracotomy and thoracoscopy: postoperative pulmonary function, pain and chest wall complaints. Eur J Cardiothorac Surg. 1997 Jul;12(1):82-7. doi: 10.1016/s1010-7940(97)00105-x.

  PMID: 9262085 BACKGROUND

• Steegers MA, Snik DM, Verhagen AF, van der Drift MA, Wilder-Smith OH. Only half of the chronic pain after thoracic surgery shows a neuropathic component. J Pain. 2008 Oct;9(10):955-61. doi: 10.1016/j.jpain.2008.05.009. Epub 2008 Jul 16.

  PMID: 18632308 BACKGROUND

• Steinthorsdottir KJ, Wildgaard L, Hansen HJ, Petersen RH, Wildgaard K. Regional analgesia for video-assisted thoracic surgery: a systematic review. Eur J Cardiothorac Surg. 2014 Jun;45(6):959-66. doi: 10.1093/ejcts/ezt525. Epub 2013 Nov 27.

  PMID: 24288340 BACKGROUND

• Adhikary SD, Pruett A, Forero M, Thiruvenkatarajan V. Erector spinae plane block as an alternative to epidural analgesia for post-operative analgesia following video-assisted thoracoscopic surgery: A case study and a literature review on the spread of local anaesthetic in the erector spinae plane. Indian J Anaesth. 2018 Jan;62(1):75-78. doi: 10.4103/ija.IJA_693_17.

  PMID: 29416155 BACKGROUND

• Shariat A, Bhatt H. Successful Use of Serratus Plane Block as Primary Anesthetic for Video-Assisted Thoracoscopic Surgery (VATS)-Assisted Pleural Effusion Drainage. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):e31-e32. doi: 10.1053/j.jvca.2017.10.038. Epub 2017 Oct 31. No abstract available.

  PMID: 29199049 BACKGROUND

• Khalil KG, Boutrous ML, Irani AD, Miller CC 3rd, Pawelek TR, Estrera AL, Safi HJ. Operative Intercostal Nerve Blocks With Long-Acting Bupivacaine Liposome for Pain Control After Thoracotomy. Ann Thorac Surg. 2015 Dec;100(6):2013-8. doi: 10.1016/j.athoracsur.2015.08.017. Epub 2015 Oct 24.

  PMID: 26507422 BACKGROUND

• Parascandola SA, Ibanez J, Keir G, Anderson J, Plankey M, Flynn D, Cody C, De Marchi L, Margolis M, Blair Marshall M. Liposomal bupivacaine versus bupivacaine/epinephrine after video-assisted thoracoscopic wedge resectiondagger. Interact Cardiovasc Thorac Surg. 2017 Jun 1;24(6):925-930. doi: 10.1093/icvts/ivx044.

  PMID: 28329326 BACKGROUND

• Rice DC, Cata JP, Mena GE, Rodriguez-Restrepo A, Correa AM, Mehran RJ. Posterior Intercostal Nerve Block With Liposomal Bupivacaine: An Alternative to Thoracic Epidural Analgesia. Ann Thorac Surg. 2015 Jun;99(6):1953-60. doi: 10.1016/j.athoracsur.2015.02.074. Epub 2015 Apr 23.

  PMID: 25912739 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Nada Sadek
• Organization: University of Iowa Health Care

nada-sadek@uiowa.edu

3193562108

Study Officials

• Nada Sadek, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: April 28, 2021
• Study Start: February 2, 2021
• Primary Completion: August 1, 2024
• Study Completion: January 30, 2025
• Last Updated: May 6, 2026
• Results First Posted: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD will be available for sharing immediately after publication and ending 5 years following article publication.
• Access Criteria: IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.

Locations

US (1)