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

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ClinicalTrials.gov Identifier: NCT01599403
Recruitment Status : Completed
First Posted : May 16, 2012
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Gyorgy Frendl, Brigham and Women's Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Traumatic Rib Fracture Procedure: Paravertebral Block Procedure: Intercostal Nerve Block Procedure: Epidural Block Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : April 2012
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : February 1, 2017

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Arm Intervention/treatment
Active Comparator: Paravertebral Block
Patients will receive 1 or 2 paravertebral catheters for ongoing infusion of local anesthestic
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
Standard usual care
Experimental: Epidural Block

Intervention:

Patients will have epidural catheters placed for the infusion of local anesthetic solution to control pain (if qualified for this approach and randomized here)

Procedure: Epidural Block
The epidural block consists of continuous infusion of local anesthetics into the epidural catheter placed into the epidural space (next to the spinal column) and results in regional pain control. This technique of this block may be performed at the appropriate level so the pain of rib fracture may be better controlled.

Active Comparator: Intercostal Nerve Block
Patients will receive intercostal catheters for the infusion of local anesthetic solution to control pain(if qualified for this arm and randomized here)
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.




Primary Outcome Measures :
  1. Primary Outcome: Difference in Pain Scores at 48hrs [ Time Frame: 2 days ]
    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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599403


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Gyorgy Frendl, MD, PhD Brigham and Women's Hospital

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
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017

Keywords provided by Gyorgy Frendl, 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
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents