Postoperative Pain Control With Lipossomic Extended Release Bupivacaine

Phase 1

• Conditions: Lung Cancer; Pain, Postoperative
• Interventions: Drug: Bupivacaine / Epinephrine; Drug: Bupivacaine liposome

• Registration Number: NCT03560362
• Lead Sponsor: University of Tennessee

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-07-09
• Status Verified: 2018-06
• Study First Submitted: 2018-06-06
• Study First Submitted QC: 2018-06-06
• Study First Posted: 2018-06-18
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-20
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine with epinephrine	Bupivacaine / Epinephrine	Patients will receive intraoperative intercostal nerve block with bupivacaine
Lipossomal extended release bupivacaine	Bupivacaine liposome	Patients will receive intraoperative intercostal nerve block with lipossomal extended release bupivacaine

Primary Outcome Measures

Name	Time	Method
Postoperative pain	3-5 days post op	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.

Secondary Outcome Measures

Name	Time	Method
Narcotic used	3-5 days post op	Amount of morphine equivalent dosage used in the postoperative period
Postoperative complications	90 days post op	Any complication occuring in the first 90 days classified according to the Clavien-Dindo classification.

Trial Locations

Locations (1)

Methodist University Hospital; 🇺🇸 Memphis, Tennessee, United States