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Completed

NCT Number: NCT03190551

Retroclavicular Versus 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.

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Key information

Conditions

Disorder of Upper Extremity

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, 07100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

retroclavicular approach

Other

Retroclavicular approach for ultrasound guided infraclavicular brachial plexus block

costoclavicular approach

Other

costoclavicular approach for ultrasound guided infraclavicular brachial plexus block

Primary outcomes

  1. Needle shaft visibility

    Time frame: 10 minutes after the needle inserted the skin

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

Secondary outcomes

  1. Technique duration

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

    Number of seconds needed to complete the block, from time of local skin anesthesia until regional block needle removal.

  2. Patient satisfaction using a visual analogue scale

    Time frame: Assessed 24 hours after the block

    Using a visual analog scala, patients will quantify their satisfaction with the retroclavicular and costaclavicular technique .

  3. supplemental analgesic used

    Time frame: 90 minutes after block completion

    The use of supplementary local anesthetic and the use of intravenous narcotics were recorded.

  4. complications such as pneumothorax, hemothorax, intraarterial injection, intravenous injection

    Time frame: 24 hours

    Asked about possible complications

  5. motor block success rate

    Time frame: Assessed 40 minutes after block completion

    Success is defined as complete motor block in the distribution of the radial, median, ulnar, musculocutaneous nerves of the forearm and hand

  6. Success Rate of the sensorial Block

    Time frame: Assessed 30 minutes after block completion

    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

  7. Block performance related pain

    Time frame: 10 minutes after the needle inserted the skin

    Block performance related pain was evaluated with a visual analog scala after the removal of the needle.

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 19, 2017
Registry last updated
Jun 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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