Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Analgesic Effect of Intravenous Patient-Controlled Analgesia (IV PCA) Versus Paravertebral Block After Video Assisted Thoracic Surgery (VATS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01538914
First received: February 16, 2012
Last updated: April 19, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention
Postoperative Pain After Video Assisted Thoracic Surgery
Procedure: paravertebral block
Procedure: PCA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison Between the Analgesic Effect of Intravenous Patient-controlled Analgesia and of Paravertebral Block After Video Assisted Thoracoscopic Surgery

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • severity of acute postoperative pain when moving [ Time Frame: 24 hours after VATS ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: February 2013
Study Completion Date: October 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PVB
Postoperative pain is controlled with local analgesics delivered via PVB.
Procedure: paravertebral block
Postoperative pain is controlled with local analgesics via PVB.
Active Comparator: PCA
Postoperatve pain is controlled with intravenous PCA.
Procedure: PCA
Postoperative pain is controlled with intravenous PCA.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients receiving video assisted thoracic surgery

Exclusion Criteria:

  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538914

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

Responsible Party: Jae-Hyon Bahk, MD, PhD, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01538914     History of Changes
Other Study ID Numbers: JHBahk_VATS PVB 
Study First Received: February 16, 2012
Last Updated: April 19, 2016
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016