Postoperative Pain Control With Lipossomic Extended Release Bupivacaine

Lung Cancer Clinical Trial

Official title:

Randomized Trial Comparing Bupivacaine vs Lipossomic Extended Release Bupivacaine for Postoperative Pain Control After Minimally Invasive Thoracic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03560362
• Other study ID #: 15-03838
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 9, 2015
• Est. completion date: October 31, 2018

Study information

• Verified date: June 2018
• Source: University of Tennessee Health Science Center
• Contact: Benny Weksler, MD
• Phone: 901-448-2918
• Email: bweksler[@]uthsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized trial of intraoperative intercostal block with bupivacaine with epinephrine compared to lipossomal extended release bupivacaine.

Description:

Patients undergoing minimally invasive thoracic surgery will be randomized to receive 0.05% bupivacaine with 1:200,000 epinephrine (control group) or extended release lipossomal bupivacaine. Primary outcomes are postoperative pain measured by visual analog scale, amount of morphine equivalent narcotics used, and postoperative complications. Patients are excluded if they undergo open thoracotomy, or minimally invasive decortication.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Patients who will be undergoing minimally invasive thoracic surgery

• Patients who will be undergoing minimally invasive thoracic surgery

Exclusion Criteria:

• Open surgery

• Chronic use of narcotics

• Use of pregabalin or similar

• Significant liver or kidney dysfunction

Related Conditions & MeSH terms

• Lung Cancer
• Pain, Postoperative

Intervention

Drug:
• Bupivacaine liposome

• Bupivacaine / Epinephrine

Locations

Country	Name	City	State
United States	Methodist University Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee Health Science Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Pain assessment with Visual Analog Scale (VAS). This is a numeric pain scale widely used in healthcare that ranks pain from 0 (no pain) to 10 (unbearable pain). A pain score below 3 is considered good.	3-5 days post op
Secondary	Postoperative complications	Any complication occuring in the first 90 days classified according to the Clavien-Dindo classification.	90 days post op
Secondary	Narcotic used	Amount of morphine equivalent dosage used in the postoperative period	3-5 days post op