Retroclavicular Versus Coracoid Approach for Infraclavicular Brachial Plexus Block
|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.
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|