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Retroclavicular Versus Coracoid Approach for Infraclavicular Brachial Plexus Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673086
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Antalya Training and Research Hospital

Brief Summary:
The primary aim of this study is to compare needle tip visibility between the coracoid approach and retroclavicular approach for infraclavicular brachial plexus block in patients undergoing elective upper limb surgery. Secondary aim is to investigate the differences between the two groups in the needle shaft visibility, sensorial block success rate, block performance time, block performance related pain, motor block success rate, surgical success rate, complications, patient satisfaction, use of supplemental local anesthetic, use of analgesic.

Condition or disease Intervention/treatment Phase
Disorder of Upper Extremity Other: coracoid approach Other: retroclavicular approach Not Applicable

Detailed Description:
Infraclavicular blocks are performed with different approaches. Infraclavicular block is usually traditionally performed at coracoid approach. Different approaches has been described for this block such as vertical approach. This study evaluated the effectiveness, safety and feasibility of a retroclavicular brachial plexus block as compared with traditionally coracoid approach for infraclavicular brachial plexus block. 100 patients scheduled for elective upper limb surgery were recruited and randomized into two groups: Coracoid approach for infraclavicular block (Group I), retroclavicular approach for infraclavicular block (Group R). Sensory block, adverse effects and complications were evaluated and recorded every 10 minutes until 30min after local anesthetic injection.Success rate of each nerve sensory block, complications, rate of satisfaction, rate of failure and incidence rate of adverse effects, the needle tip and shaft visibility, procedure time,duration of the block's effect, use of supplemental local anesthetic, use of analgesic.are compared with both groups.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. supplemental analgesic use [ Time Frame: 90 minutes after block completion ]
    the need for additional intravenous analgesic

  5. 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.

  6. 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)

  7. 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).

  8. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who undergo elective forearm or hand surgery under infraclavicular brachial plexus block
  • American Society of Anesthesiologists class 1 to 3
  • Ability to consent

Exclusion Criteria:

  • History of allergic reaction to local anaesthetics
  • Peripheral neuropathy
  • Renal or hepatic insufficiency
  • Coagulation disorders

Information from the National Library of Medicine

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


Locations
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Turkey
Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Antalya, Turkey, 07100
Sponsors and Collaborators
Antalya Training and Research Hospital
Investigators
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Study Director: Nılgun Kavrut Ozturk, MD Antalya Training and Research Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Antalya Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02673086    
Other Study ID Numbers: AntalyaTRH 010
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Antalya Training and Research Hospital:
retroclavicular approach
coracoid approach
ultrasound
upper limb surgery
needle visibility
infraclavicular brachial plexus block