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Completed

NCT Number: NCT02673086

Retroclavicular Versus Coracoid Approach for Infraclavicular Brachial Plexus Block

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.

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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. 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.

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

coracoid approach

Other

Coracoid approach for ultrasound guided infraclavicular brachial plexus block

retroclavicular approach

Other

retroclavicular approach for ultrasound guided infraclavicular brachial plexus block

Primary outcomes

  1. Needle visibility

    Time frame: 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 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 the first insertion of the blocking needle to its removal.

  2. Patient satisfaction using a visual analogue scale

    Time frame: Assessed 48 hours after the block

    Using a visual analogue scale , patients will quantify their satisfaction with the retroclavicular coracoid technique.

  3. Surgical success rate

    Time frame: 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.

  4. supplemental analgesic use

    Time frame: 90 minutes after block completion

    the need for additional intravenous analgesic

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

    Time frame: 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.

  6. motor block success rate

    Time frame: 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)

  7. Success Rate of the sensorial Block

    Time frame: 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).

  8. Block performance related pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 3, 2016
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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