- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04554186
Serratus Anterior Plane Block Versus Thoracic Paravertebral Block.
Ultrasound Guided Serratus Anterior Plane Block Versus Thoracic Paravertebral Block in Emergency Department Rib Fracture
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study will be conducted in a prospective randomised controlled. Patients will be allocated into three groups
Control group:
The patient will receive fentanyl patch 50 microgram
TPVB group:
The patient will receive thoracic vertebral plane lock 0.4ml/kg bupivacaine 0.1 25% will be administered. For continuous infusion catheter will be inserted . Then a rate of 7ml / hour to max 10 ml / hour of bupivacaine 0.0625%
SAPB group,:
Patient will receive serratus anterior plane block 0.4ml / kg bupivacaine 0.125% will be injected to open the space then a catheter will be advanced For continuous infusion of 0.0625 % bupivacaine at 7 ml / hour
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed G Shehata, Master
- Phone Number: 0020 1067622270
- Email: ahmedgamalicu@gmail.com
Study Contact Backup
- Name: Omyma M Shehata, MD
- Phone Number: 0020 1061762894
- Email: omyma.shehata44@yahoo.com
Study Locations
-
-
-
Minya, Egypt, 61511
- Recruiting
- Minia University Hospital
-
Contact:
- Ahmed G Shehata, Master
- Phone Number: 0020 1067622270
- Email: ahmedgamalicu@gmail.com
-
Contact:
- Omyma M Shehata, MD
- Phone Number: 0020 1061762894
- Email: omyma.shehata44@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA 1_3 Age 18_60 Unilateral fracture ribs
Exclusion Criteria:
- Drug allergy Morbid obese Opioid dependence Patients refuse
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Serratus anterior plane block
20 patients will receive SAP block with 0.4 ml / kg bupivacaine 0.125% then continuous infusion through a catheter at rate of 7 ml / hour to max 10 ml / hour of bupivacaine 0.0625%
|
Injection of bupivacaine between serratus anterior plane and latissimus dorsi muscle using ultrasound
|
ACTIVE_COMPARATOR: Thoracic Paravertebral block
20 patients will receive TPVB 0.4ml / kg bupivacaine 0.125% then continuous infusion through a catheter at rate of 7 ml / hour to max 10 ml / hour of bupivacaine 0.0625%
|
Injection of bupivacaine in the thoracic Paravertebral space using ultrasound
|
PLACEBO_COMPARATOR: Control group
20 patients will receive Fentanyl patch 50 microgram
|
Place a fentanyl patch 50 microgram
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS score
Time Frame: 24 hour
|
Visual analogue pain score describe by the patient
|
24 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total analgesic consumption
Time Frame: 24 hour
|
Total opioid consume by the patient in 24 hour
|
24 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Amany K Aboelhassan, Minia University Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 112-11/2018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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