Retroclavicular Versus Costoclavicular Approach for Infraclavicular Brachial Plexus Block

NCT03190551 | Completed

• 1 other identifier: AntalyaTRH15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to compare needle shaft visibility between the retroclavicular approach and costoclavicular 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 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

infraclavicular brachial plexus block; retroclavicular approach; costoclavicular approach; upper limb surgery; needle shaft visibility

Outcome Measures

Primary Outcomes (1)

• Needle shaft visibility

  Needle visibility reviewed by two anesthesiologists using a 5-point Likert scale

  10 minutes after the needle inserted the skin

Secondary Outcomes (7)

• Technique duration

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

• Patient satisfaction using a visual analogue scale

  Assessed 24 hours after the block

• supplemental analgesic used

  90 minutes after block completion

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

  24 hours

• motor block success rate

  Assessed 40 minutes after block completion

Study Arms (2)

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

costoclavicular approach

ACTIVE COMPARATOR

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

Other: costoclavicular approach

Interventions

retroclavicular approach OTHER

Retroclavicular approach for ultrasound guided infraclavicular brachial plexus block

retroclavicular approach

costoclavicular approach OTHER

costoclavicular approach for ultrasound guided infraclavicular brachial plexus block

costoclavicular 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

Study Officials

• Hayri Fatih Metinyurt, MD

  Antalya Training and Research Hospital

  STUDY DIRECTOR

• Nilgun Kavrut Ozturk, MD

  Antalya Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Ali Sait Kavakli, MD

  Antalya Training and Research Hospital

  PRINCIPAL INVESTIGATOR

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: June 12, 2017
• First Posted: June 19, 2017
• Study Start: January 1, 2017
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: June 19, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)