Pain Control of Thoracoscopic Major Pulmonary Resection | NCT01758809

Studies
Pain Control of Thoracoscopic Major Pulmonary Resection

NCT01758809

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Jan 1, 2013Estimated

Enrollment

86Actual

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

Pre-emptive bupivacaine wound infiltration
intravenous patient controlled analgesia

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Sep 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Sep 28, 2011

First Submission Date that Met QC Criteria

Dec 25, 2012

First Posted Date

Jan 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 25, 2012

Last Update Posted Date

Jan 1, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sanghoon Jheon, Chief, Department of Thoracic and Cardiovascular Surgery, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

86Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bupivacaine	Active Comparator		Procedure: Pre-emptive bupivacaine wound infiltration
Intravenous Patient Controlled Analgesia	Other	postoperative pain control with intravenous patient controlled analgesia	Procedure: intravenous patient controlled analgesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pre-emptive bupivacaine wound infiltration	Procedure	Pre-emptive bupivacaine wound infiltration	Bupivacaine

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sanghoon Jheon, M.D., Ph.D.	Seoul National University Bundang Hospital	Study Chair
Hee Chul Yang, M.D.	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	463-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016058	Analgesia, Patient-Controlled

Ancestor Terms

ID	Term
D000698	Analgesia
D000760	Anesthesia and Analgesia

Browse Leaves

Not provided

Browse Branches

Not provided