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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01039870
Other study ID # YTKim_PVB_Postthor Pain
Secondary ID
Status Completed
Phase N/A
First received December 23, 2009
Last updated February 16, 2012
Start date July 2010
Est. completion date February 2012

Study information

Verified date February 2012
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
paravertebral block
postoperative pain is controlled with local analgesics delivered via PVB
thoracic epidural analgesia
postoperative pain is controlled with local analgesics and fentanyl delivered via thoracic epidural catheter

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and severity of acute postthoracotomy pain when moving 24 hours after thoracotomy No
Secondary Incidence of chronic postthoracotomy pain 6 months after thoracotomy No