Retroclavicular Versus Coracoid Approach for Infraclavicular Brachial Plexus Block

Not Applicable

Completed

• Conditions: Disorder of Upper Extremity
• Interventions: Other: retroclavicular approach; Other: coracoid approach

• Registration Number: NCT02673086
• Lead Sponsor: Antalya Training and Research Hospital

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.

Detailed Description

Infraclavicular blocks are performed with different approaches. Infraclavicular block is usually traditionally performed at coracoid approach. Different approaches has been described for this block such as vertical approach. This study evaluated the effectiveness, safety and feasibility of a retroclavicular brachial plexus block as compared with traditionally coracoid approach for infraclavicular brachial plexus block. 100 patients scheduled for elective upper limb surgery were recruited and randomized into two groups: Coracoid approach for infraclavicular block (Group I), retroclavicular approach for infraclavicular block (Group R). Sensory block, adverse effects and complications were evaluated and recorded every 10 minutes until 30min after local anesthetic injection.Success rate of each nerve sensory block, complications, rate of satisfaction, rate of failure and incidence rate of adverse effects, the needle tip and shaft visibility, procedure time,duration of the block's effect, use of supplemental local anesthetic, use of analgesic.are compared with both groups.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-03
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2017-06-15
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Needle visibility	10 minutes after the needle inserted the skin	To assess the needle visibility will be reviewed by two anesthesiologists using a 5-point Likert scale.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction using a visual analogue scale	Assessed 48 hours after the block	Using a visual analogue scale , patients will quantify their satisfaction with the retroclavicular coracoid technique.
supplemental analgesic use	90 minutes after block completion	the need for additional intravenous analgesic
complications such as pneumothorax, hemothorax, intraarterial injection, intravenous injection	24 hours	Patients are asked about possible complications and all the patients studied is evaluated by performing bedside ultrasound examinations of the chest before discharge.
Technique duration	Time required in seconds for the block completion (10 minutes)	Number of seconds needed to complete the block, from time the first insertion of the blocking needle to its removal.
Surgical success rate	6 hours after the block	Surgical success is defined as no requirement for additional local anesthetic and the use of intravenous analgesic, rescue blocks, or general anesthesia during the surgery.
Success Rate of the sensorial Block	Assessed 30 minutes after block completion	Sensory assessments are performed every 5 minutes after needle removal for 30 minute in the regions of the radial, median, ulnar, musculocutaneous of the forearm based on a three point scale with cold test ( 0: normal sensation, 1:analgesia, 2: anesthesia).
motor block success rate	Assessed 40 minutes after block completion	Motor function is evaluate for flexion of the elbow, opposition of the thumb, and adduction of the thumb based on a three point scale (0 = normal strength, 1 = paresis, 2 = paralysis)
Block performance related pain	10 minutes after the needle inserted the skin	Block performance related pain is evaluated with a verbal rating scale score after the removel of the needle.

Trial Locations

Locations (1)

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation; 🇹🇷 Antalya, Turkey