Pain Control of Thoracoscopic Major Pulmonary Resection

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01758809
• Other study ID #: B-1009-111-015
• Status: Completed
• Phase: N/A
• First received: September 28, 2011
• Last updated: December 25, 2012
• Start date: December 2010
• Est. completion date: November 2011

Study information

• Verified date: December 2012
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: November 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Pre-emptive bupivacaine wound infiltration
Pre-emptive bupivacaine wound infiltration
• intravenous patient controlled analgesia
postoperative pain control with intravenous patient controlled analgesia

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	number of participants with adverse events related to fentanyl or bupivacaine drug	nausea, vomiting, sleepiness, urinary difficulty, respiratory depression	2 months	Yes