Retroclavicular Versus Coracoid Approach for Infraclavicular Brachial Plexus Block
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|ClinicalTrials.gov Identifier: NCT02673086|
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : June 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Disorder of Upper Extremity||Other: coracoid approach Other: retroclavicular approach||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Could the Retroclavicular Block Alternative for Ultrasound-guided Infraclavicular Block: A Prospective Randomized Controlled Trial|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||June 2016|
Active Comparator: coracoid approach
Patients in this group will be randomized to receive an coracoid approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block .
Other: coracoid approach
Coracoid approach for ultrasound guided infraclavicular brachial plexus block
Active Comparator: retroclavicular approach
Patients in this group will be randomized to receive an retroclavicular approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block .
Other: retroclavicular approach
retroclavicular approach for ultrasound guided infraclavicular brachial plexus block
- Needle visibility [ Time Frame: 10 minutes after the needle inserted the skin ]To assess the needle visibility will be reviewed by two anesthesiologists using a 5-point Likert scale.
- Technique duration [ Time Frame: Time required in seconds for the block completion (10 minutes) ]Number of seconds needed to complete the block, from time the first insertion of the blocking needle to its removal.
- Patient satisfaction using a visual analogue scale [ Time Frame: Assessed 48 hours after the block ]Using a visual analogue scale , patients will quantify their satisfaction with the retroclavicular coracoid technique.
- Surgical success rate [ Time Frame: 6 hours after the block ]Surgical success is defined as no requirement for additional local anesthetic and the use of intravenous analgesic, rescue blocks, or general anesthesia during the surgery.
- supplemental analgesic use [ Time Frame: 90 minutes after block completion ]the need for additional intravenous analgesic
- complications such as pneumothorax, hemothorax, intraarterial injection, intravenous injection [ Time Frame: 24 hours ]Patients are asked about possible complications and all the patients studied is evaluated by performing bedside ultrasound examinations of the chest before discharge.
- motor block success rate [ Time Frame: Assessed 40 minutes after block completion ]Motor function is evaluate for flexion of the elbow, opposition of the thumb, and adduction of the thumb based on a three point scale (0 = normal strength, 1 = paresis, 2 = paralysis)
- Success Rate of the sensorial Block [ Time Frame: Assessed 30 minutes after block completion ]Sensory assessments are performed every 5 minutes after needle removal for 30 minute in the regions of the radial, median, ulnar, musculocutaneous of the forearm based on a three point scale with cold test ( 0: normal sensation, 1:analgesia, 2: anesthesia).
- Block performance related pain [ Time Frame: 10 minutes after the needle inserted the skin ]Block performance related pain is evaluated with a verbal rating scale score after the removel of the needle.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673086
|Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation|
|Antalya, Turkey, 07100|
|Study Director:||Nılgun Kavrut Ozturk, MD||Antalya Training and Research Hospital|