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Completed

NCT Number: NCT04471025

Jedi Grip Versus Double Operator Technique For Ultrasound Guided Infraclavicular Block

The investigators aimed to compare the block characteristics of the single operator "jedi grip" technique and the conventional double operator technique.

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Key information

Conditions

Ultrasound Nerve Block

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara City Hospital

Ankara, 06600, Turkey (Türkiye)

About this study

Patients undergoing hand, wrist, elbow and forearm surgery randomly assigned two groups (Group I: Jedi grip and Group II: Conventional double operator technique). By a blind observer, the block characteristics were evaluated and recorded .

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • undergoing elective hand, wrist and forearm surgery

Exclusion criteria

  • hepatic or renal failure
  • serious cardiac or pulmoner disease
  • local or systemic infection
  • sepsis
  • coagulation disorder
  • neurological, muscular or psychiatric disease
  • body mass index (BMI) below 18.5 or above 35
  • drug and substance abuse
  • pregnancy
  • refusal of regional anesthesia
  • history of allergy to local anesthetics
  • mental-motor retardation (inability to consent or assess the visual analog scale(VAS) pain score)
  • preoperative long-term NSAIDs or opioid use.

Treatment and study plan

USG guided infraclavicular block

Procedure

USG guided infraclavicular block was applied to patients either by conventional two-person technique or by one person Jedi technique according to the allocated group. On Group I single operator controlled the probe with one hand while controlling the needle and the syringe on the other hand with the Jedi technique. The needle was held between the index finger and the middle phalanx of the middle finger, and the syringe was held with fingers 4 and 5, with the plunger part to the thumb in the palm. On Group II, operator used the probe and needle with different hands while an assistant controlling the syringe to aspirate or inject local anesthetic.

Primary outcomes

  1. block performance time

    Time frame: during block application

    teh sum of imaging and needling time

  2. block success

    Time frame: during surgery

    incidence of ( %) surgery with successful anesthesia

Secondary outcomes

  1. Sensory block onset time

    Time frame: before surgery

    Sensory blockage was evaluated and graded; from lateral to the forearm, the volar face of the thumb, volar face of the 5th finger and lateral side of the hand back; for musculocutaneous, median, ulnar and radial nerves, respectively. Graduation was according to a previously validated 3-point scale using a cold test: 0 = no block, 1 = analgesia (patient can feel touch, not cold), and 2 = anesthesia (patient cannot feel touch)

  2. motor block onset time

    Time frame: before surgery

    blockage was evaluated and graded; with elbow flexion, thumb abduction, thumb opposition, thumb adduction for musculocutaneous, radial, median, ulnar nerves respectively. Motor blockage graduation was also according to a (validated) 3-point scale: 0 = no block, 1 = paresis and 2 = paralysis.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

A Prospective, Randomized, Observer-Blinded Comparison Between Single And Double Operator In Ultrasound Guided Infraclavicular Block: Jedi Grip Versus Conventional Double Operator Technique

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 14, 2020
Registry last updated
Jul 14, 2020

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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