Determination of Minimum Effective Volume of Local Anesthetic in Patients Undergoing Ultrasound-Guided Infraclavicular Approach for Brachial Plexus Blockade

NCT03838120 | Completed Phase 4

• 1 other identifier: AnkaranTRH1
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 İnfraclavicular Approach for Brachial Plexus Blockade in upper limb operations.

Conditions

Underdosing of Local Anesthetics; Anesthetics, Local; Peripheral Nervous System Agents; Physiological Effects of Drugs

Keywords

Ultrasound; Minimum; Infraclavicular block

Outcome Measures

Primary Outcomes (1)

• minimum effective volume

  Determining the minimum effective volume of bupivacaine 0,5% for successful ultrasound guided infraclavicular brachial plexus block for upper limb surgery

  A blinded Assistant assess sensory and motor blockade in a 5-min intervals up to 60 minutes.

Secondary Outcomes (4)

• Successful blockade onset time

  A blinded Assistant assess sensory and motor blockade in a 5-min intervals up to 60 minutes.

• Regression time of sensorial blockade

  post-op 2, 4, 8, 12, 16, and 24 hours.

• Regression time of motor blockade

  post-op 2, 4, 8, 12, 16, and 24 hours.

• Time of first additional analgesic requirement

  The post-operative pain of patients was evaluated via the visual analogue scale (VAS) at post-op 2, 4, 8, 12, 16, and 24 hours

Study Arms (1)

Bupivacaine 0,5% Single arm study

OTHER

Bupivacaine 0,5% Single arm study

Other: Procedure/Surgery: bupivakain % 0,5

Interventions

Procedure/Surgery: bupivakain % 0,5 OTHER

In this study, 5 patients were included in each volume group and at least 3 applications out of 5 had to be successful to consider the volume to be sufficient. After a successful group, the volume was reduced by 2 ml's and the same procedure was followed until a final group with unsuccessful anesthesia was found (≤2 successful blockades). The study was ended at this point and MEV was determined as the volume used in the last successful group. The researcher which determined the success of blockade was blinded to the study protocol. BMI, ASA Score, Successful blockade onset time Regression time of sensorial blockade Regression time of motor blockade Time of first additional analgesic requirement

Bupivacaine 0,5% Single arm study

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18-70 years of age who were determined as ASA I-III and underwent upper limb surgery from November 2015 to November 2016 and provided informed consent, were included in the study.

You may not qualify if:

• Patients who had any of the following conditions were excluded: ASA risk score of IV or V, serious cardiac, respiratory, hepatic or renal comorbidities, mental disorder, coagulopathy, pregnancy, local anesthetic allergy, neuromuscular and/or neurological disease, and infection at the site of injection. Patients who were unwilling to participate were also excluded

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 48 ASA I-II patients underwent upper limb surgery operation by administering USG guided-infraclavicular blockage were included in the study. brachial plexus were seen and the minimum effective LA volume was investigated starting with total 30 ml of %0.5 bupivacain. After accomplishing the blockage, volume was decreased 2ml. Block administration time, block onset times, anesthesia times and time to first analgesic requirement were recorded.

Study Record Dates

• First Submitted: February 10, 2019
• First Posted: February 12, 2019
• Study Start: November 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 27, 2021

Record last verified: 2019-02