Pain Control of Thoracoscopic Major Pulmonary Resection

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is a better alternative pain control modality than the conventional intravenous patient controlled analgesia.

Detailed Description
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Despite less postoperative pain from Video Assisted Thoracic Surgery (VATS) than thoracotomy, pain is still an important issue in its recovery period. After VATS procedure, intravenous patient controlled analgesia (IV PCA) is being used for pain control. However, the side effects of IV PCA are nausea, vomiting, sleepiness, and urination difficulty which interrupt the early recovery. It is established that pre-emptive local bupivacaine injection is more economical, has almost no side effects, and finally, it is effective for the postoperative 24 hours. The purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is a better alternative pain control modality than the conventional intravenous patient controlled analgesia.

Official Title
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Pain Control of Thoracoscopic Major Pulmonary Resection: Is Pre-emptive Local Bupivacaine Injection Able to Replace the Intravenous Patient Controlled Analgesia?

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Pre-emptive bupivacaine wound infiltration
* Procedure: intravenous patient controlled analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients that are expected to receive VATS segmenectomy or lobectomy regardless of disease entity Exclusion Criteria: not done by VATS anatomical resection patient does not agree to the study postoperative hospital stay exceeds 7 days due to postoperative complications existence of preoperative renal insufficiency (Cr > 1.5) OT/PT > 120 history of Lidocaine hypersensitivity
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<br> | Procedure: Pre-emptive bupivacaine wound infiltration<br>* Pre-emptive bupivacaine wound infiltration<br>|
| Other: Intravenous Patient Controlled Analgesia<br>postoperative pain control with intravenous patient controlled analgesia | Procedure: intravenous patient controlled analgesia<br>* postoperative pain control with intravenous patient controlled analgesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in postoperative pain confirmed by Visual Analogue Pain Scale |  | Operation day, Postoperative Day 1, 2, 3 and 2 week, 1 month, 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with adverse events related to fentanyl or bupivacaine drug | nausea, vomiting, sleepiness, urinary difficulty, respiratory depression | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Video Assisted Thoracic Surgery, Postoperative Pain, Intravenous Patient Controlled Analgesia, Bupivacaine, Major Pulmonary Resection, Post Pulmonary Resection