Pain Control of Thoracoscopic Major Pulmonary Resection

NCT ID: NCT01758809

Last Updated: 2013-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-11-30

Brief Summary

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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

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bupivacaine

Group Type ACTIVE_COMPARATOR

Pre-emptive bupivacaine wound infiltration

Intervention Type PROCEDURE

Pre-emptive bupivacaine wound infiltration

Intravenous Patient Controlled Analgesia

postoperative pain control with intravenous patient controlled analgesia

Group Type OTHER

intravenous patient controlled analgesia

Intervention Type PROCEDURE

postoperative pain control with intravenous patient controlled analgesia

Interventions

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Pre-emptive bupivacaine wound infiltration

Pre-emptive bupivacaine wound infiltration

Intervention Type PROCEDURE

intravenous patient controlled analgesia

postoperative pain control with intravenous patient controlled analgesia

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sanghoon Jheon

Chief, Department of Thoracic and Cardiovascular Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sanghoon Jheon, M.D., Ph.D.

Role: STUDY_CHAIR

Seoul National University Bundang Hospital

Hee Chul Yang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B-1009-111-015

Identifier Type: -

Identifier Source: org_study_id

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