Jedi Grip Versus Double Operator Technique For Ultrasound Guided Infraclavicular Block

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

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

Study Overview

• Status: Completed
• Conditions: Ultrasound; Nerve Block
• Intervention / Treatment: Procedure: USG guided infraclavicular block

Detailed Description

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 .

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06600
    • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I; USG guided infraclavicular block with single operator jedi grip technique	Procedure: USG guided infraclavicular block; 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.
Active Comparator: Group 2; USG guided infraclavicular block with conventional double operator technique	Procedure: USG guided infraclavicular block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
block performance time	teh sum of imaging and needling time	during block application
block success	incidence of ( %) surgery with successful anesthesia	during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory block onset time	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)	before surgery
motor block onset time	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.	before surgery

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: İsmail Aytac, Ankara City Hospital Anesthesiology Department

Publications and helpful links

General Publications

• Pappin D, Christie I. The Jedi Grip: a novel technique for administering local anaesthetic in ultrasound-guided regional anaesthesia. Anaesthesia. 2011 Sep;66(9):845. doi: 10.1111/j.1365-2044.2011.06845.x. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2018
• Primary Completion (Actual): May 3, 2019
• Study Completion (Actual): May 3, 2019

Study Registration Dates

• First Submitted: July 4, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Jedi Grip; Ultrasound guided infraclavicular block
• Other Study ID Numbers: E-18-1935

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No