Video-assisted Thoracoscopic Surgery - Exparel Study

Nada Sadek

Status and phase: Completed; Phase 2

Conditions: Pain, Postoperative

Treatments: Drug: Bupivacaine; Drug: Liposomal bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04864210

201901777

Details and patient eligibility

About

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.

Full 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.

Enrollment: 176 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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176 participants in 2 patient groups

Liposomal bupivacaine

Experimental group

Description:

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).

Treatment:

Drug: Liposomal bupivacaine

Bupivacaine

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine