Thoracic Blocks Versus Thoracic Epidural and Patient Controlled Anesthesia in Traumatic Rib Fracture Patients
Comparative Effectiveness of Continuous Thoracic Paravertebral Blocks Versus Thoracic Epidural and Continuous Intercostal Blocks Versus Patient-Controlled Anesthesia in Traumatic Rib Fracture Patients
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedFirst Posted
Study publicly available on registry
May 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedFebruary 13, 2017
February 1, 2017
4.8 years
February 28, 2012
February 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Outcome: Difference in Pain Scores at 48hrs
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.
2 days
Study Arms (4)
Paravertebral Block
ACTIVE COMPARATORPatients will receive 1 or 2 paravertebral catheters for ongoing infusion of local anesthestic
Patient Controlled Anesthesia
NO INTERVENTIONStandard usual care
Epidural Block
EXPERIMENTALIntervention: Patients will have epidural catheters placed for the infusion of local anesthetic solution to control pain (if qualified for this approach and randomized here)
Intercostal Nerve Block
ACTIVE COMPARATORPatients will receive intercostal catheters for the infusion of local anesthetic solution to control pain(if qualified for this arm and randomized here)
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gyorgy Frendl, MD, PhD
Brigham and Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Surgical ICU Translational Research (STAR) Center
Study Record Dates
First Submitted
February 28, 2012
First Posted
May 16, 2012
Study Start
April 1, 2012
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
February 13, 2017
Record last verified: 2017-02