Pain Control of Thoracoscopic Major Pulmonary Resection

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: intravenous patient controlled analgesia; Procedure: Pre-emptive bupivacaine wound infiltration

• Registration Number: NCT01758809
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2011-09
• Study First Submitted: 2011-09-28
• Study Completion: 2011-11
• Status Verified: 2012-12
• Study First Submitted QC: 2012-12-25
• Last Update Submitted: 2012-12-25
• Study First Posted: 2013-01-01
• Last Update Posted: 2013-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• patients that are expected to receive VATS segmenectomy or lobectomy regardless of disease entity

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous Patient Controlled Analgesia	intravenous patient controlled analgesia	postoperative pain control with intravenous patient controlled analgesia
Bupivacaine	Pre-emptive bupivacaine wound infiltration	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
number of participants with adverse events related to fentanyl or bupivacaine drug	2 months	nausea, vomiting, sleepiness, urinary difficulty, respiratory depression

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of