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Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03508830
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Johannes R. Kratz, MD, University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Thoracic Diseases Postoperative Pain Opioid Use Drug: Liposomal Bupivacaine Drug: Standard Bupivacaine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Syringe with Obscuring Over-Wrap
Primary Purpose: Treatment
Official Title: Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial - Liposomal Bupivacaine Versus Standard Bupivacaine
Actual Study Start Date : December 30, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Liposomal Bupivacaine Drug: Liposomal Bupivacaine
Drug will be percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision at the conclusion of surgery.

Active Comparator: Standard Bupivacaine Drug: Standard Bupivacaine
Drug will be percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision at the conclusion of surgery.




Primary Outcome Measures :
  1. Daily In-Hospital Use of Opioids [ Time Frame: 24 Hours ]
    Measured in Oral Morphine Equivalents


Secondary Outcome Measures :
  1. Daily In-Hospital Pain Score [ Time Frame: 24 Hours ]
    Measured 0-10 Visual Analog Scale for Pain

  2. Mean Time to First Opioid Use [ Time Frame: Postoperative Day 0 ]
    Measured in Hours

  3. Mean Time to Ambulation [ Time Frame: Postoperative Day 0 ]
    Measured in Hours

  4. Pulmonary Complication [ Time Frame: Index Hospitalization following Surgery until Discharge - Up to 1 Week ]
    Presence of Atelectasis (requiring bronchoscopy) or Pneumonia

  5. Length of Stay [ Time Frame: Index Hospitalization following Surgery until Discharge - Up to 1 Week ]
    Measured in Days

  6. Total Opioid Prescription at Discharge [ Time Frame: Day of Discharge - Up to 24 Hours ]
    Measured in Oral Morphine Equivalents

  7. Total Opioid Use as Outpatient [ Time Frame: 2 Weeks ]
    Measured in Oral Morphine Equivalents

  8. Direct Costs of Hospital Encounter [ Time Frame: Index Hospitalization following Surgery until Discharge - Up to 1 Week ]
    Includes Direct Costs of Surgery and Hospitalization

  9. Quality of Life: Short-Form-8 Health Survey [ Time Frame: 4 Weeks ]
    Obtained in the pre and postoperative clinic visits



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508830


Contacts
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Contact: Greg J Haro, MD 415-353-8196 greg.haro@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Greg J Haro, MD       greg.haro@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
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Responsible Party: Johannes R. Kratz, MD, Assistant Professor of Surgery Division of Adult Cardiothoracic Surgery; Van Auken Endowed Chair in Thoracic Oncology; Director, Minimally Invasive and Robotic Thoracic Surgery; Associate Director, Thoracic Surgery Residency Program, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03508830    
Other Study ID Numbers: P0530291
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johannes R. Kratz, MD, University of California, San Francisco:
Liposomal Bupivacaine
Intercostal Nerve Block
Minimally Invasive Thoracic Surgery
Additional relevant MeSH terms:
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Thoracic Diseases
Respiratory Tract Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents