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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01039870
First received: December 23, 2009
Last updated: February 16, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Acute Postthoracotomy Pain
Chronic Postthoracotomy Pain
Hypotension After Bolus Dose
 Procedure: paravertebral block
Procedure: thoracic epidural analgesia

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Incidence and severity of acute postthoracotomy pain when moving [ Time Frame: 24 hours after thoracotomy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of chronic postthoracotomy pain [ Time Frame: 6 months after thoracotomy ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: July 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039870

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Young-Tae Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01039870     History of Changes
Other Study ID Numbers: YTKim_PVB_Postthor Pain
Study First Received: December 23, 2009
Last Updated: February 16, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
postthoracotomy pain

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013