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Pain Control of Thoracoscopic Major Pulmonary Resection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanghoon Jheon, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01758809
First received: September 28, 2011
Last updated: December 25, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Postoperative Pain
 Procedure: Pre-emptive bupivacaine wound infiltration
Procedure: intravenous patient controlled analgesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pain Control of Thoracoscopic Major Pulmonary Resection: Is Pre-emptive Local Bupivacaine Injection Able to Replace the Intravenous Patient Controlled Analgesia?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • The change in postoperative pain confirmed by Visual Analogue Pain Scale [ Time Frame: Operation day, Postoperative Day 1, 2, 3 and 2 week, 1 month, 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of participants with adverse events related to fentanyl or bupivacaine drug [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    nausea, vomiting, sleepiness, urinary difficulty, respiratory depression


Enrollment: 86
Study Start Date: December 2010
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bupivacaine Procedure: Pre-emptive bupivacaine wound infiltration
Pre-emptive bupivacaine wound infiltration
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758809

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Sanghoon Jheon, Chief, Department of Thoracic and Cardiovascular Surgery, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01758809     History of Changes
Other Study ID Numbers: B-1009-111-015
Study First Received: September 28, 2011
Last Updated: December 25, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Bundang Hospital:
Video Assisted Thoracic Surgery
Postoperative Pain
Intravenous Patient Controlled Analgesia
 Bupivacaine
Major Pulmonary Resection
Post Pulmonary Resection

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013