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

NCT02837718 | Completed Phase 4

• 1 other identifier: AnkaranTRH
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Underdosing of Local Anesthetics

Outcome Measures

Primary Outcomes (1)

• Minimum effective volume of bupivacain %0.5

  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

  1 hour

Secondary Outcomes (1)

• first analgesic requirement

  1 day (0,1, 2, 4, 6, 8, 10, 12, 18, 24 hours)

Study Arms (1)

Bupivacaine 0,5% Single arm study

OTHER

Bupivacaine 0,5% Single arm study

Procedure: bupivakain % 0,5

Interventions

bupivakain % 0,5 PROCEDURE

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.

Bupivacaine 0,5% Single arm study

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2016
• First Posted: July 20, 2016
• Study Start: December 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 13, 2020

Record last verified: 2018-12