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Minimum Effective Volume Of Local Anesthetic İn USG Guided Axillary Approach Brachial Plexus Block

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ClinicalTrials.gov Identifier: NCT02837718
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
necati alper erdoğmuş, Ankara City Hospital Bilkent

Brief Summary:

Background Peripheral nerve blocks with use of USG allowed visualisation of the structures and nerves and made the block administrations safe, quick and comfortable. However there are few publications concerning the minimum local anesthetic volume capable of providing blocks. In this study the investigastors aimed to find Minimum Effective Volume Of Local Anesthetic For Ultrasound-Guided Axillary Brachial Plexus Block in hand, elbow and forehand operations.

Materials & Methods A total of 55 ASA I-II patients underwent hand surgery operation by administering USG guided-axillary brachial plexus blockage were included in the study. Ulnar, median and radial nerves were seen and the minimum effective local anesthetic volume was investigated starting with total 21 ml of %0.5 bupivacain. After accomplishing the blockage, volume was decreased by 0.5 for each nerves. Block administration time, block onset times, anesthesia times and time to first analgesic requirement were recorded.


Condition or disease Intervention/treatment Phase
Underdosing of Local Anesthetics Procedure: bupivakain % 0,5 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Intervention Model: Sequential Assignment
Intervention Model Description: A total of 55 ASA I-II patients underwent hand surgery operation by administering USG guided-axillary brachial plexus blockage were included in the study. Ulnar, median and radial nerves were seen and the minimum effective LA volume was investigated starting with total 21 ml of %0.5 bupivacain. After accomplishing the blockage, volume was decreased by 0.5 for each nerves. Block administration time, block onset times, anesthesia times and time to first analgesic requirement were recorded.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Minimum Effective Volume Of Local Anesthetic İn USG Guided Axillary Approach Brachial Plexus Block
Study Start Date : December 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Bupivacaine 0,5% Single arm study
Bupivacaine 0,5% Single arm study
Procedure: bupivakain % 0,5
Bupivacaine 0,5% The study method was a step-up/step-down sequence model where the dose for following patients was determined by the outcome of the preceding block. The starting dose of bupivacaine was 5 mL per nerve. In the case of block failure, the dose was increased by 0.5 mL per nerve. Conversely, block success resulted in a reduction in dose by 0.5 mL per nerve. Each of the three nerves was treated as a separate entity. Dose adjustments were made to each nerve individually. The volume dose was increased in 0.5 mL at every 5 consecutive cases regardless of the result of the previous block in order to minimize bias occurence. A blinded assistant assessed sensory and motor blockade at 5-min intervals up to 30 min.




Primary Outcome Measures :
  1. Minimum effective volume of bupivacain %0.5 [ Time Frame: 1 hour ]
    Ulnar, median and radial nerves were seen and the minimum effective local anesthetic volume was investigated starting with total 21 ml of %0.5 bupivacain. After accomplishing the blockage, volume was decreased by 0.5 for each nerves


Secondary Outcome Measures :
  1. first analgesic requirement [ Time Frame: 1 day (0,1, 2, 4, 6, 8, 10, 12, 18, 24 hours) ]
    Time of Visual analogue scale (VAS) over than 4. Measurument starts after operation finish.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • were age over 18 and under 65 years
  • informed consent (IC) signed by the patient
  • indication for brachial plexus block (anesthesia and analgesia) in candidates forelective hand surgery
  • ASA physical status I or II according to the American Society of Anesthesiologists
  • body mass index (BMI) <35 kg/m2.

Exclusion Criteria:

  • Cognitive impairment or active psychiatriccondition
  • İnfection at the blockade puncture site
  • Bleeding disorders
  • History of local anesthetic allergy
  • Pregnancy
  • The patients does not want this method .
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Responsible Party: necati alper erdoğmuş, Dr, Ankara City Hospital Bilkent
ClinicalTrials.gov Identifier: NCT02837718    
Other Study ID Numbers: AnkaranTRH
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided