Postoperative Pain Control With Lipossomic Extended Release Bupivacaine

Study Overview
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Brief Summary
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Randomized trial of intraoperative intercostal block with bupivacaine with epinephrine compared to lipossomal extended release bupivacaine.

Detailed Description
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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.

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

Conditions
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Pain, Postoperative, Lung Cancer

Intervention / Treatment
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* Drug: Bupivacaine liposome
* Drug: Bupivacaine / Epinephrine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine with epinephrine<br>Patients will receive intraoperative intercostal nerve block with bupivacaine | Drug: Bupivacaine / Epinephrine<br> <br> |
| Experimental: Lipossomal extended release bupivacaine<br>Patients will receive intraoperative intercostal nerve block with lipossomal extended release bupivacaine | Drug: Bupivacaine liposome<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bupivacaine, lipossomal extended release bupivacaine, Intercostal nerve block, thoracic surgery, minimally invasive surgery