Retroclavicular Versus Costoclavicular Approach for Infraclavicular Brachial Plexus Block

Disorder of Upper Extremity Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Retroclavicular and Costoclavicular Approach for Infraclavicular Brachial Plexus Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03190551
• Other study ID #: AntalyaTRH15
• Status: Completed
• Phase: N/A
• First received: June 12, 2017
• Last updated: June 15, 2017
• Start date: January 2017
• Est. completion date: April 2017

Study information

• Verified date: June 2017
• 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 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.

Description:

Infraclavicular blocks are performed with different approaches. This study evaluated the effectiveness, safety and feasibility of a retroclavicular brachial plexus block as compared with costoclavicular approach for infraclavicular brachial plexus block. 60 patients scheduled for elective upper limb surgery were recruited and randomized into two groups: Retroclavicular approach for infraclavicular block (Group I), costoclavicular approach for infraclavicular block (Group R). Sensory block, adverse effects and complications were evaluated and recorded every 5 minutes until 30 min 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 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: 60
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• 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:
• retroclavicular approach
Retroclavicular approach for ultrasound guided infraclavicular brachial plexus block
• costoclavicular approach
costoclavicular 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 shaft visibility	Needle visibility 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 of local skin anesthesia until regional block needle removal.	Time required in seconds for the block completion (10 minutes)
Secondary	Patient satisfaction using a visual analogue scale	Using a visual analog scala, patients will quantify their satisfaction with the retroclavicular and costaclavicular technique .	Assessed 24 hours after the block
Secondary	supplemental analgesic used	The use of supplementary local anesthetic and the use of intravenous narcotics were recorded.	90 minutes after block completion
Secondary	complications such as pneumothorax, hemothorax, intraarterial injection, intravenous injection	Asked about possible complications	24 hours
Secondary	motor block success rate	Success is defined as complete motor block in the distribution of the radial, median, ulnar, musculocutaneous nerves of the forearm and hand	Assessed 40 minutes after block completion
Secondary	Success Rate of the sensorial Block	Success is defined as complete sensory loss in the distribution of the radial, median, ulnar, musculocutaneous, and medial cutaneous nerves of the forearm and hand	Assessed 30 minutes after block completion
Secondary	Block performance related pain	Block performance related pain was evaluated with a visual analog scala after the removal of the needle.	10 minutes after the needle inserted the skin