Back to resultsThe Effect of Paravertebral Block Using a Multi-orifice Catheter on Preventing Acute and Chronic Post-thoracotomy Pain
Primary Purpose
Acute Postthoracotomy Pain, Chronic Postthoracotomy Pain, Hypotension After Bolus Dose
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
paravertebral block
thoracic epidural analgesia
Sponsored by
About this trial
This is an interventional treatment trial for Acute Postthoracotomy Pain focused on measuring postthoracotomy pain
Eligibility 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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PVB
TEA
Arm Description
Paravertebral block initiated at the later part of thoracotomy is used for postoperative pain control
Thoracic epidural block initiated before the surgical incision is used for postoperative pain control.
Outcomes
Primary Outcome Measures
Incidence and severity of acute postthoracotomy pain when moving
Secondary Outcome Measures
Incidence of chronic postthoracotomy pain
Full Information
NCT ID
NCT01039870
First Posted
December 23, 2009
Last Updated
February 16, 2012
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01039870
Brief Title
The Effect of Paravertebral Block Using a Multi-orifice Catheter on Preventing Acute and Chronic Post-thoracotomy Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Postthoracotomy Pain, Chronic Postthoracotomy Pain, Hypotension After Bolus Dose
Keywords
postthoracotomy pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PVB
Arm Type
Experimental
Arm Description
Paravertebral block initiated at the later part of thoracotomy is used for postoperative pain control
Arm Title
TEA
Arm Type
Active Comparator
Arm Description
Thoracic epidural block initiated before the surgical incision is used for postoperative pain control.
Intervention Type
Procedure
Intervention Name(s)
paravertebral block
Intervention Description
postoperative pain is controlled with local analgesics delivered via PVB
Intervention Type
Procedure
Intervention Name(s)
thoracic epidural analgesia
Intervention Description
postoperative pain is controlled with local analgesics and fentanyl delivered via thoracic epidural catheter
Primary Outcome Measure Information:
Title
Incidence and severity of acute postthoracotomy pain when moving
Time Frame
24 hours after thoracotomy
Secondary Outcome Measure Information:
Title
Incidence of chronic postthoracotomy pain
Time Frame
6 months after thoracotomy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of Paravertebral Block Using a Multi-orifice Catheter on Preventing Acute and Chronic Post-thoracotomy Pain
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