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Completed

NCT Number: NCT01758809

Pain Control of Thoracoscopic Major Pulmonary Resection

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre-emptive bupivacaine wound infiltration

Procedure

Pre-emptive bupivacaine wound infiltration

intravenous patient controlled analgesia

Procedure

postoperative pain control with intravenous patient controlled analgesia

Primary outcomes

  1. 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

Secondary outcomes

  1. number of participants with adverse events related to fentanyl or bupivacaine drug

    Time frame: 2 months

    nausea, vomiting, sleepiness, urinary difficulty, respiratory depression

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 1, 2013
Registry last updated
Jan 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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