Retroclavicular Versus Coracoid Approach for Infraclavicular Brachial Plexus Block

Disorder of Upper Extremity Clinical Trial

Official title:

Could the Retroclavicular Block Alternative for Ultrasound-guided Infraclavicular Block: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02673086
• Other study ID #: AntalyaTRH 010
• Status: Completed
• Phase: N/A
• First received: January 19, 2016
• Last updated: June 15, 2017
• Start date: December 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Disorder of Upper Extremity

Intervention

Other:
• coracoid approach
Coracoid approach for ultrasound guided infraclavicular brachial plexus block
• retroclavicular approach
retroclavicular approach for ultrasound guided infraclavicular brachial plexus block

Locations

Country	Name	City	State
Turkey	Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Technique duration	Number of seconds needed to complete the block, from time the first insertion of the blocking needle to its removal.	Time required in seconds for the block completion (10 minutes)
Secondary	Patient satisfaction using a visual analogue scale	Using a visual analogue scale , patients will quantify their satisfaction with the retroclavicular coracoid technique.	Assessed 48 hours after the block
Secondary	Surgical success rate	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.	6 hours after the block
Secondary	supplemental analgesic use	the need for additional intravenous analgesic	90 minutes after block completion
Secondary	complications such as pneumothorax, hemothorax, intraarterial injection, intravenous injection	Patients are asked about possible complications and all the patients studied is evaluated by performing bedside ultrasound examinations of the chest before discharge.	24 hours
Secondary	motor block success rate	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)	Assessed 40 minutes after block completion
Secondary	Success Rate of the sensorial Block	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).	Assessed 30 minutes after block completion
Secondary	Block performance related pain	Block performance related pain is evaluated with a verbal rating scale score after the removel of the needle.	10 minutes after the needle inserted the skin