Pain Control of Thoracoscopic Major Pulmonary Resection

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

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 Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Pre-emptive bupivacaine wound infiltration; Procedure: 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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacaine	Procedure: Pre-emptive bupivacaine wound infiltration; Pre-emptive bupivacaine wound infiltration
Other: Intravenous Patient Controlled Analgesia; postoperative pain control with intravenous patient controlled analgesia	Procedure: intravenous patient controlled analgesia; postoperative pain control with intravenous patient controlled analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Study Chair: Sanghoon Jheon, M.D., Ph.D., Seoul National University Bundang Hospital; Principal Investigator: Hee Chul Yang, M.D., Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: September 28, 2011
• First Submitted That Met QC Criteria: December 25, 2012
• First Posted (Estimate): January 1, 2013

Study Record Updates

• Last Update Posted (Estimate): January 1, 2013
• Last Update Submitted That Met QC Criteria: December 25, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Postoperative Pain; Bupivacaine; Video Assisted Thoracic Surgery; Intravenous Patient Controlled Analgesia; Major Pulmonary Resection; Post Pulmonary Resection
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: B-1009-111-015