Back to resultsUltrasound Guided Axillary Brachial Plexus Block Versus Supraclavicular Block in Emergency Crushed Hand Patients
Primary Purpose
the Study Focuses on Comparing Between Supraclavicular and Axillary Blocks
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
brachial plexus block
Sponsored by
About this trial
This is an interventional other trial for the Study Focuses on Comparing Between Supraclavicular and Axillary Blocks
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
axillary brachial plexus block group
supraclavicular brachial plexus block group
Arm Description
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
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
Outcomes
Primary Outcome Measures
block related complications
failed block, motor weakness 24 h after the block, vascular puncture, Horner syndrome, paresthesia and pneumothorax
Secondary Outcome Measures
number of first needle pass
how many times the needle is inserted till we can inject local anesthesia in a proper site
Full Information
NCT ID
NCT03377985
First Posted
December 7, 2017
Last Updated
December 17, 2017
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT03377985
Brief Title
Ultrasound Guided Axillary Brachial Plexus Block Versus Supraclavicular Block in Emergency Crushed Hand Patients
Official Title
Ultrasound Guided Axillary Brachial Plexus Block Versus Supraclavicular Block in Emergency Crushed Hand Patients: A Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 30, 2016 (Actual)
Study Completion Date
December 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
the Study Focuses on Comparing Between Supraclavicular and Axillary Blocks
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
axillary brachial plexus block group
Arm Type
Active Comparator
Arm Description
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
Arm Title
supraclavicular brachial plexus block group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
brachial plexus block
Other Intervention Name(s)
nerve block
Primary Outcome Measure Information:
Title
block related complications
Description
failed block, motor weakness 24 h after the block, vascular puncture, Horner syndrome, paresthesia and pneumothorax
Time Frame
24 hours after the block
Secondary Outcome Measure Information:
Title
number of first needle pass
Description
how many times the needle is inserted till we can inject local anesthesia in a proper site
Time Frame
10-20 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Ultrasound Guided Axillary Brachial Plexus Block Versus Supraclavicular Block in Emergency Crushed Hand Patients
We'll reach out to this number within 24 hrs