ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01039870
Recruitment Status : Completed
First Posted : December 25, 2009
Last Update Posted : February 20, 2012
Sponsor:
Information provided by:
Seoul National University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Postthoracotomy Pain Chronic Postthoracotomy Pain Hypotension After Bolus Dose Procedure: paravertebral block Procedure: thoracic epidural analgesia Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

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



Primary Outcome Measures :
  1. Incidence and severity of acute postthoracotomy pain when moving [ Time Frame: 24 hours after thoracotomy ]

Secondary Outcome Measures :
  1. Incidence of chronic postthoracotomy pain [ Time Frame: 6 months after thoracotomy ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039870


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

Responsible Party: Young-Tae Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01039870     History of Changes
Other Study ID Numbers: YTKim_PVB_Postthor Pain
First Posted: December 25, 2009    Key Record Dates
Last Update Posted: February 20, 2012
Last Verified: February 2012

Keywords provided by Seoul National University Hospital:
postthoracotomy pain

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases