Retroclavicular Versus Costoclavicular Approach for Infraclavicular Brachial Plexus Block

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

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.

Study Overview

• Status: Completed
• Conditions: Disorder of Upper Extremity
• Intervention / Treatment: Other: retroclavicular approach; Other: costoclavicular approach

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey, 07100
    • Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: retroclavicular approach; Patients in this group will be randomized to receive an retroclavicular approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block .	Other: retroclavicular approach; Retroclavicular approach for ultrasound guided infraclavicular brachial plexus block
Active Comparator: costoclavicular approach; Patients in this group will be randomized to receive an costoclavicular approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block .	Other: costoclavicular approach; costoclavicular approach for ultrasound guided infraclavicular brachial plexus block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Needle shaft visibility	Needle visibility reviewed by two anesthesiologists using a 5-point Likert scale	10 minutes after the needle inserted the skin

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
supplemental analgesic used	The use of supplementary local anesthetic and the use of intravenous narcotics were recorded.	90 minutes after block completion
complications such as pneumothorax, hemothorax, intraarterial injection, intravenous injection	Asked about possible complications	24 hours
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
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
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

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital
• Investigators: Principal Investigator: Nilgun Kavrut Ozturk, MD, Antalya Training and Research Hospital; Principal Investigator: Ali Sait Kavakli, MD, Antalya Training and Research Hospital; Study Director: Hayri Fatih Metinyurt, MD, Antalya Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: June 12, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Actual): June 19, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: costoclavicular approach; infraclavicular brachial plexus block; retroclavicular approach; upper limb surgery; needle shaft visibility
• Other Study ID Numbers: AntalyaTRH15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No