NCT01039870

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 25, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 20, 2012

Status Verified

February 1, 2012

Enrollment Period

1.6 years

First QC Date

December 23, 2009

Last Update Submit

February 16, 2012

Conditions

Acute Postthoracotomy PainChronic Postthoracotomy PainHypotension After Bolus Dose

Keywords

postthoracotomy pain

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of acute postthoracotomy pain when moving

    24 hours after thoracotomy

Secondary Outcomes (1)

  • Incidence of chronic postthoracotomy pain

    6 months after thoracotomy

Study Arms (2)

PVB

EXPERIMENTAL

Paravertebral block initiated at the later part of thoracotomy is used for postoperative pain control

Procedure: paravertebral block

TEA

ACTIVE COMPARATOR

Thoracic epidural block initiated before the surgical incision is used for postoperative pain control.

Procedure: thoracic epidural analgesia

Interventions

paravertebral blockPROCEDURE

postoperative pain is controlled with local analgesics delivered via PVB

PVB
thoracic epidural analgesiaPROCEDURE

postoperative pain is controlled with local analgesics and fentanyl delivered via thoracic epidural catheter

TEA

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients receiving surgery through a thoracotomy incision

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 23, 2009

First Posted

December 25, 2009

Study Start

July 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 20, 2012

Record last verified: 2012-02

Locations

KR(1)