Retroclavicular Versus Coracoid Approach for Infraclavicular Brachial Plexus Block

NCT02673086 | Completed

• 1 other identifier: AntalyaTRH 010
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Upper Extremity

Keywords

retroclavicular approach; coracoid approach; ultrasound; upper limb surgery; needle visibility; infraclavicular brachial plexus block

Outcome Measures

Primary Outcomes (1)

• Needle visibility

  To assess the needle visibility will be reviewed by two anesthesiologists using a 5-point Likert scale.

  10 minutes after the needle inserted the skin

Secondary Outcomes (8)

• Technique duration

  Time required in seconds for the block completion (10 minutes)

• Patient satisfaction using a visual analogue scale

  Assessed 48 hours after the block

• Surgical success rate

  6 hours after the block

• supplemental analgesic use

  90 minutes after block completion

• complications such as pneumothorax, hemothorax, intraarterial injection, intravenous injection

  24 hours

Study Arms (2)

coracoid approach

ACTIVE COMPARATOR

Patients in this group will be randomized to receive an coracoid approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block .

Other: coracoid approach

retroclavicular approach

ACTIVE COMPARATOR

Patients in this group will be randomized to receive an retroclavicular approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block .

Other: retroclavicular approach

Interventions

coracoid approach OTHER

Coracoid approach for ultrasound guided infraclavicular brachial plexus block

coracoid approach

retroclavicular approach OTHER

retroclavicular approach for ultrasound guided infraclavicular brachial plexus block

retroclavicular approach

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

You may not qualify if:

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

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, 07100, Turkey (Türkiye)

Location

Related Publications (1)

• Kavrut Ozturk N, Kavakli AS. Comparison of the coracoid and retroclavicular approaches for ultrasound-guided infraclavicular brachial plexus block. J Anesth. 2017 Aug;31(4):572-578. doi: 10.1007/s00540-017-2359-6. Epub 2017 Apr 18.

  PMID: 28421316 DERIVED

Study Officials

• Nılgun Kavrut Ozturk, MD

  Antalya Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: February 3, 2016
• Study Start: December 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 19, 2017

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)