Back to resultsMinimally Invasive Thoracic Surgery Intercostal Nerve Block Trial
Primary Purpose
Thoracic Diseases, Postoperative Pain, Opioid Use
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
Bupivacaine Injection
Sponsored by
About this trial
This is an interventional treatment trial for Thoracic Diseases focused on measuring Liposomal Bupivacaine, Intercostal Nerve Block, Minimally Invasive Thoracic Surgery
Eligibility 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
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Liposomal Bupivacaine
Standard Bupivacaine
Arm Description
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. Drug Preparation: 266mg (20cc) Liposomal Bupivacaine admixed with 0.25% (2.5mg/cc) Standard Bupivacaine (maximum dose of 2mg/kg) and varied 0.9% normal saline volume for total volume of 60cc.
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. Drug Preparation - 0.25% (2.5mg/cc) Standard Bupivacaine (maximum dose of 2mg/kg) admixed with varied 0.9% normal saline volume for total volume of 60cc.
Outcomes
Primary Outcome Measures
Average Daily In-Hospital Use of Opioids
Measured in Oral Morphine Equivalents per Day
Secondary Outcome Measures
Average Daily In-Hospital Pain Score
Measured 0-10 Visual Analog Scale for Pain (Higher Score Means Worse Pain).
Number of Participants With Postoperative Pneumonia
Pneumonia (Y/N)
Length of Stay
Measured in Days
Full Information
NCT ID
NCT03508830
First Posted
March 23, 2018
Last Updated
May 12, 2021
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT03508830
Brief Title
Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial
Official Title
Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial - Liposomal Bupivacaine Versus Standard Bupivacaine
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 30, 2018 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
January 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Diseases, Postoperative Pain, Opioid Use
Keywords
Liposomal Bupivacaine, Intercostal Nerve Block, Minimally Invasive Thoracic Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Syringe with Obscuring Over-Wrap
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liposomal Bupivacaine
Arm Type
Experimental
Arm Description
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.
Drug Preparation: 266mg (20cc) Liposomal Bupivacaine admixed with 0.25% (2.5mg/cc) Standard Bupivacaine (maximum dose of 2mg/kg) and varied 0.9% normal saline volume for total volume of 60cc.
Arm Title
Standard Bupivacaine
Arm Type
Active Comparator
Arm Description
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.
Drug Preparation - 0.25% (2.5mg/cc) Standard Bupivacaine (maximum dose of 2mg/kg) admixed with varied 0.9% normal saline volume for total volume of 60cc.
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Injection
Intervention Description
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 Outcome Measure Information:
Title
Average Daily In-Hospital Use of Opioids
Description
Measured in Oral Morphine Equivalents per Day
Time Frame
Average over Entire Length of Hospitalization (Up to 1 Week)
Secondary Outcome Measure Information:
Title
Average Daily In-Hospital Pain Score
Description
Measured 0-10 Visual Analog Scale for Pain (Higher Score Means Worse Pain).
Time Frame
Average over Length of Hospitalization - Up to 1 Week
Title
Number of Participants With Postoperative Pneumonia
Description
Pneumonia (Y/N)
Time Frame
Index Hospitalization following Surgery until Discharge - Up to 1 Week
Title
Length of Stay
Description
Measured in Days
Time Frame
Index Hospitalization following Surgery until Discharge - Up to 1 Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial
We'll reach out to this number within 24 hrs