- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03377985
Ultrasound Guided Axillary Brachial Plexus Block Versus Supraclavicular Block in Emergency Crushed Hand Patients
December 17, 2017 updated by: Rania Maher Hussien, Ain Shams University
Ultrasound Guided Axillary Brachial Plexus Block Versus Supraclavicular Block in Emergency Crushed Hand Patients: A Comparative Study
The current study focused on ultrasound guided brachial plexus block (BPB) which plays an important role in patients with hand trauma either in pain control or for surgical intervention.
The brachial plexus can be blocked by several techniques but the most commonly used are the supraclavicular (SCB) and axillary (AXB) blocks.
Aim of this study is to compare between the two techniques as regard performance time, needling time, anesthesia related time, block related complications, number of needle pass, and block related pain.
80 patients were allocated randomly into two equal groups, under ultrasound guidance the SCB and AXB were done for the two groups respectively.
The needling time, performance time, anesthesia related time, onset time, number of 1st needle pass in each group and block related complications were noted.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with ASA physical status II and III, and body mass index (BMI) between 20 and 35, aged 40-70, undergoing emergency crushed hand surgery
Exclusion Criteria:
- Patients with significant coagulopathy, infection or trauma at the injection site of local anesthetics, allergy to local anesthetics, refusal to participate, known neuropathies patients, mentally retarded patients, severely trauma patients who required general anesthesia from the start in the pre-induction room, and unconscious patients due to the accident. Also, shocked patients and patients with chronic obstructive airway disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: axillary brachial plexus block group
Patients placed in the supine position with arm to be blocked abducted and externally rotated.
After sterilization of the axilla ultrasound device with high frequency of 8-12 MHZ, linear transducer was put parallel to the anterior axillary fold at axilla to identify the axillary artery, lateral, medial and posterior cords of the brachial plexus in relation to the axillary artery.
Lidocaine 1% was infiltrated subcutaneously 1 cm lateral to the probe, 7-10 ml of bupivacaine 0.5% was injected around each cord of the brachial plexus
|
Other Names:
|
Active Comparator: supraclavicular brachial plexus block group
patients placed in the supine position with the head of the bed elevated 30 degrees and patient's head turned away from the side to be blocked after skin disinfection, ultrasound device was put transversely parallel to and above the middle third of the clavicle, the probe was tilted till identification of the subclavian artery, 1st rib, pleura and brachial plexus lateral to the subclavian artery and above the 1st rib.
Lidocaine 1% was infiltrated subcutaneously 1 cm lateral to the lateral side of the probe.
A needle was inserted in plane 1 cm lateral to the probe when adjacent to brachial plexus 25 ml of bubivacaine 0.5% was injected around the brachial plexus
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
block related complications
Time Frame: 24 hours after the block
|
failed block, motor weakness 24 h after the block, vascular puncture, Horner syndrome, paresthesia and pneumothorax
|
24 hours after the block
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of first needle pass
Time Frame: 10-20 min
|
how many times the needle is inserted till we can inject local anesthesia in a proper site
|
10-20 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
December 30, 2016
Study Completion (Actual)
December 30, 2016
Study Registration Dates
First Submitted
December 7, 2017
First Submitted That Met QC Criteria
December 17, 2017
First Posted (Actual)
December 19, 2017
Study Record Updates
Last Update Posted (Actual)
December 19, 2017
Last Update Submitted That Met QC Criteria
December 17, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FWA 000017585
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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