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Completed

NCT Number: NCT03508830

Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial

The Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial is a single center, double-blind, randomized, active-comparator controlled clinical trial to assess the analgesic efficacy of intercostal nerve block by Liposomal Bupivacaine versus Standard Bupivacaine in subjects undergoing lung resection by robotic or video-assisted thoracoscopic surgery.

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Key information

Conditions

Thoracic Diseases Neurologic Manifestations Opioid Use Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Respiratory Tract Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Robotic or Video-Assisted Lung Resection for All Indications

Exclusion criteria

  • Additional Thoracic Procedures (beyond lung resection and mediastinal lymphadenectomy)
  • Extra-Thoracic Procedures
  • Hypersensitivity to Amide Local Analgesia
  • Cardiac Conduction Abnormalities
  • Hepatic Dysfunction
  • Preoperative Neuropathic Pain and/or Preoperative Daily Opioid Usage

Treatment and study plan

Liposomal bupivacaine

Drug

5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery.

Bupivacaine Injection

Drug

5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery.

Primary outcomes

  1. Average Daily In-Hospital Use of Opioids

    Time frame: Average over Entire Length of Hospitalization (Up to 1 Week)

    Measured in Oral Morphine Equivalents per Day

Secondary outcomes

  1. Average Daily In-Hospital Pain Score

    Time frame: Average over Length of Hospitalization - Up to 1 Week

    Measured 0-10 Visual Analog Scale for Pain (Higher Score Means Worse Pain).

  2. Number of Participants With Postoperative Pneumonia

    Time frame: Index Hospitalization following Surgery until Discharge - Up to 1 Week

    Pneumonia (Y/N)

  3. Length of Stay

    Time frame: Index Hospitalization following Surgery until Discharge - Up to 1 Week

    Measured in Days

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial - Liposomal Bupivacaine Versus Standard Bupivacaine

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 26, 2018
Registry last updated
Jun 8, 2021

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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