NCT01538914

Brief Summary

The purpose of this study is to compare the analgesic effect of paravertebral block with that of intravenous patient-controlled analgesia after video assisted thoracic surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

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

February 16, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 24, 2012

Completed
11 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

2 years

First QC Date

February 16, 2012

Last Update Submit

April 19, 2016

Conditions

Postoperative Pain After Video Assisted Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

  • severity of acute postoperative pain when moving

    24 hours after VATS

Study Arms (2)

PVB

EXPERIMENTAL

Postoperative pain is controlled with local analgesics delivered via PVB.

Procedure: paravertebral block

PCA

ACTIVE COMPARATOR

Postoperatve pain is controlled with intravenous PCA.

Procedure: PCA

Interventions

paravertebral blockPROCEDURE

Postoperative pain is controlled with local analgesics via PVB.

PVB
PCAPROCEDURE

Postoperative pain is controlled with intravenous PCA.

PCA

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients receiving video assisted thoracic surgery

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 VATS
  • 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, South Korea

Location

MeSH Terms

Interventions

Passive Cutaneous Anaphylaxis

Intervention Hierarchy (Ancestors)

Skin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic TechniquesAntigen-Antibody ReactionsImmune System Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 16, 2012

First Posted

February 24, 2012

Study Start

February 1, 2013

Primary Completion

February 1, 2015

Study Completion

October 1, 2015

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

KR(1)