Retroclavicular Approach vs Infraclavicular Approach for Brachial Plexus Block in Obese Patients
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The retroclavicular approach for brachial plexus anesthesia requires an optimal angle between the needle and the ultrasound beam. Retroclavicular approach has already been proven effective and safe in the past. The general objective is to provide a formal comparison between the retroclavicular approach and coracoid infraclavicular approach for brachial plexus anaesthesia. This study should represent the differences between the two techniques.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2017
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2016
CompletedFirst Posted
Study publicly available on registry
December 13, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedDecember 13, 2016
December 1, 2016
4 months
December 9, 2016
December 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Technique duration
The performance time corresponds to the sum of imaging time and needling time. It is expressed in minutes. Analysis of the primary outcome: performance time will be analyzed with a non-inferiority test of the averages, with the objective of finding that the experimental retroclavicular approach is no longer to perform than the coracoid infraclavicular approach.
Measured directly during the procedure with a chronometer.
Surgery completion under regional block
Success rate is defined as the completion of the intended surgery under regional anaesthesia with retroclavicular block without the need for a rescue technique.
Success is defined at end of surgery for which block was done, generally within 1 to 3 hours after block is performed
Secondary Outcomes (3)
Sensorial block progression
Assessed 10, 20 and 30 minutes after block completion
Motor Block Progression
Assessed 10, 20, 30 minutes after the block completion
Needle visualization
Assessed one week after study completion
Study Arms (2)
Ultrasound guided retroclavicular block
ACTIVE COMPARATORUltrasound guided retroclavicular block group patients (Group R) will receive 30 cc %0.5 Bupivacaine
Ultrasound guided infraclavicular block
ACTIVE COMPARATORUltrasound guided coracoid infraclavicular block group patients (Group C) will receive 30 cc %0.5 Bupivacaine
Interventions
Ultrasound guided retroclavicular block for forearm or hand surgery
Ultrasound guided infraclavicular block for forearm or hand surgery
Eligibility Criteria
You may qualify if:
- years
- BMI\>30
- Forearm- Hand surgery
You may not qualify if:
- \<18 years
- Local infection
- Coagulopaty
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Proffesor
Study Record Dates
First Submitted
December 9, 2016
First Posted
December 13, 2016
Study Start
January 1, 2017
Primary Completion
May 1, 2017
Study Completion
July 1, 2017
Last Updated
December 13, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share