Thoracic Blocks Versus Thoracic Epidural and Patient Controlled Anesthesia in Traumatic Rib Fracture Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Gyorgy Frendl, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01599403
First received: February 28, 2012
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

The primary objective of this study is to investigate whether continuous PVB is equal in efficacy to epidural anesthesia in terms of analgesia in patients with INR lower than 1.2, or is continuous ICNB equal in efficacy to PCA in terms of analgesia, if patients have INRs equal to or greater than 1.2.


Condition Intervention
Traumatic Rib Fracture
Procedure: Paravertebral Block
Procedure: Intercostal Nerve Block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Comparative Effectiveness of Continuous Thoracic Paravertebral Blocks Versus Thoracic Epidural and Continuous Intercostal Blocks Versus Patient-Controlled Anesthesia in Traumatic Rib Fracture Patients

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Primary Outcome: Difference in Pain Scores at 48hrs [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    The primary question investigators wish to answer in this study is whether continuous PVB is equal in efficacy to epidural anesthesia in terms of analgesia in patients with INR lower than 1.2, or is continuous ICNB equal in efficacy to PCA in terms of analgesia, if patients have INRs equal to or greater than 1.2 as measured by visual analog pain scales at 48 hours post treatment.


Estimated Enrollment: 40
Study Start Date: April 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Paravertebral Block Procedure: Paravertebral Block
The paravertebral block consists of injection of local anesthetics into the area next to the spinal column and results in regional pain control. This technique of this block may be performed on multiple levels if there are extensive rib fractures and may be performed on both sides of the rib cage depending on injury.
No Intervention: Patient Controlled Anesthesia
No Intervention: Epidural
Active Comparator: Intercostal Nerve Block Procedure: Intercostal Nerve Block
The intercostal nerve block will consist of placing a catheter which delivers pain medication into the area between the ribs. This technique of this block may be performed on multiple levels if there are extensive rib fractures and may be performed on both sides of the rib cage depending on injury.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria

A subject must meet the following criteria to take part in the study:

Inclusion Criteria

  • Subjects 18 years of age and greater
  • Inpatient on the BWH SICU, MICU, or hospital floor ward
  • Non-intubated at the time of block placement
  • Traumatic Rib Fractures three or greater
  • Block able to be placed within 12-24 hours of presentation to the emergency room
  • Ability to provide written informed consent.
  • Compliance with all ASRA and BWH Regional Anesthesia in Anticoagulated Patient guidelines for coagulation status.

Exclusion Criteria:

  • Subject is pregnant
  • Subject not expected to survive 48 hours due to traumatic injuries
  • Allergy to Ropivacaine or other local anesthetic
  • Any significant concomitant injuries potentially confounding data acquisition (e.g., traumatic brain injury, long bone fractures, intra-abdominal injuries)
  • Known allergy to lidocaine
  • Inability to provide written, informed consent
  • Known opioid medication dependence
  • Non-compliance with ARSA and BWH Regional Anesthesia in Anticoagulated Patient Guidelines.
  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: NCT01599403

Contacts
Contact: Derek Guanaga, BS 617-732-8397 dguanaga@PARTNERS.ORG
Contact: Christopher F Calahan, BS 617-732-8224 ccalahan1@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Derek Guanaga, BS    617-732-8397    dguanaga@partners.org   
Contact: Chris Calahan, BS    617-732-8224    ccalahan1@PARTNERS.ORG   
Principal Investigator: Gyorgy Frendl, MD, PhD         
Sponsors and Collaborators
Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Gyorgy Frendl, Director, Surgical ICU Translational Research (STAR) Center, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01599403     History of Changes
Other Study ID Numbers: 2011P002702 Frendl
Study First Received: February 28, 2012
Last Updated: January 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Rib Fracture
Intercostal Nerve Block
Paravertebral Nerve Block

Additional relevant MeSH terms:
Fractures, Bone
Rib Fractures
Wounds and Injuries
Thoracic Injuries
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 09, 2014