The Effect of Paravertebral Block Using a Multi-orifice Catheter on Preventing Acute and Chronic Post-thoracotomy Pain

February 16, 2012 updated by: Seoul National University Hospital
This study aims to evaluate the effect of the paravertebral block using a multi-lumen catheter on the incidence and severity of acute and chronic postthoracotomy pain compared to the thoracic epidural block.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients receiving surgery through a thoracotomy incision

Exclusion Criteria:

  • patients with cardiovascular disease
  • patients with neurologic disease
  • patients with contraindications to paravertebral block or epidural block
  • patients with history of previous thoracotomy incision
  • patients with pain at the expected incision site

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PVB
Paravertebral block initiated at the later part of thoracotomy is used for postoperative pain control
Procedure: paravertebral block
postoperative pain is controlled with local analgesics delivered via PVB
Active Comparator: TEA
Thoracic epidural block initiated before the surgical incision is used for postoperative pain control.
Procedure: thoracic epidural analgesia
postoperative pain is controlled with local analgesics and fentanyl delivered via thoracic epidural catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of acute postthoracotomy pain when moving
Time Frame: 24 hours after thoracotomy
24 hours after thoracotomy

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of chronic postthoracotomy pain
Time Frame: 6 months after thoracotomy
6 months after thoracotomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

December 23, 2009

First Submitted That Met QC Criteria

December 24, 2009

First Posted (Estimate)

December 25, 2009

Study Record Updates

Last Update Posted (Estimate)

February 20, 2012

Last Update Submitted That Met QC Criteria

February 16, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YTKim_PVB_Postthor Pain

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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