Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03508830
• Other study ID #: P0530291
• Status: Completed
• Phase: Phase 3
• Start date: December 30, 2018
• Est. completion date: January 30, 2021

Study information

• Verified date: May 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Postoperative Pain
• Thoracic Diseases

Intervention

Drug:
• Liposomal bupivacaine
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
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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Daily In-Hospital Use of Opioids	Measured in Oral Morphine Equivalents per Day	Average over Entire Length of Hospitalization (Up to 1 Week)
Secondary	Average Daily In-Hospital Pain Score	Measured 0-10 Visual Analog Scale for Pain (Higher Score Means Worse Pain).	Average over Length of Hospitalization - Up to 1 Week
Secondary	Number of Participants With Postoperative Pneumonia	Pneumonia (Y/N)	Index Hospitalization following Surgery until Discharge - Up to 1 Week
Secondary	Length of Stay	Measured in Days	Index Hospitalization following Surgery until Discharge - Up to 1 Week