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Pain Control of Thoracoscopic Major Pulmonary Resection

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pre-emptive bupivacaine wound infiltration
intravenous patient controlled analgesia
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Video Assisted Thoracic Surgery, Postoperative Pain, Intravenous Patient Controlled Analgesia, Bupivacaine, Major Pulmonary Resection, Post Pulmonary Resection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Bupivacaine

Intravenous Patient Controlled Analgesia

Arm Description

postoperative pain control with intravenous patient controlled analgesia

Outcomes

Primary Outcome Measures

The change in postoperative pain confirmed by Visual Analogue Pain Scale

Secondary Outcome Measures

number of participants with adverse events related to fentanyl or bupivacaine drug
nausea, vomiting, sleepiness, urinary difficulty, respiratory depression

Full Information

First Posted
September 28, 2011
Last Updated
December 25, 2012
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01758809
Brief Title
Pain Control of Thoracoscopic Major Pulmonary Resection
Official Title
Pain Control of Thoracoscopic Major Pulmonary Resection: Is Pre-emptive Local Bupivacaine Injection Able to Replace the Intravenous Patient Controlled Analgesia?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Video Assisted Thoracic Surgery, Postoperative Pain, Intravenous Patient Controlled Analgesia, Bupivacaine, Major Pulmonary Resection, Post Pulmonary Resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Title
Intravenous Patient Controlled Analgesia
Arm Type
Other
Arm Description
postoperative pain control with intravenous patient controlled analgesia
Intervention Type
Procedure
Intervention Name(s)
Pre-emptive bupivacaine wound infiltration
Intervention Description
Pre-emptive bupivacaine wound infiltration
Intervention Type
Procedure
Intervention Name(s)
intravenous patient controlled analgesia
Intervention Description
postoperative pain control with intravenous patient controlled analgesia
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
number of participants with adverse events related to fentanyl or bupivacaine drug
Description
nausea, vomiting, sleepiness, urinary difficulty, respiratory depression
Time Frame
2 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanghoon Jheon, M.D., Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hee Chul Yang, M.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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Pain Control of Thoracoscopic Major Pulmonary Resection

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