Jedi Grip vs. Double Operator Technique for Axillary Brachial Plexus Block

NCT ID: NCT04463329

Last Updated: 2020-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-02-28

Brief Summary

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In this prospective randomized controlled observer-blinded study we aimed to compare the efficacy of a single operator technique so called Jedi Grip and conventional technique requiring double operator in ultrasound guided axillary brachial plexus block.

Detailed Description

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Patients aged between 18 and 65 years, American Society of Anesthesiologists (ASA) physical status I to II ) undergoing elective hand, wrist and forearm surgery were prospectively enrolled. Patients were randomly assigned to Group C (conventional technique) or group J (Jedi technique). In both groups, axillary plexus blockage was provided by applying 5cc of a mixture of 10 cc 0.5% bupivacaine and 10 cc 2% prilocaine to the ulnar, radial, median and musculocutaneous nerves. Parameters such as performance time and the number of needle passes were recorded during procedure. Subsequently, a blinded observer evaluated and recorded parameters related to the success of blockage. The main outcome variable was performance time and success rate (surgical anesthesia).

Conditions

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Brachial Plexus Block Ultrasound, Interventional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

the patients were randomly allocated to one of the two groups as Group C (conventional two-operator axillary brachial plexus blockage) and Group J (axillary brachial plexus block with single operator using Jedi grip)
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
After completion of the block, a blinded observer recorded demographic data and questioned the patients for felt pain related to the block procedure using a 10-cm visual analog scale (0 cm = no pain, 10 cm = worst imaginable pain). Patients were also questioned for symptoms related to the local anesthetic toxicity.

Subsequently, measurements of brachial plexus blockade were carried out every 5 mins until 30 mins by the same blinded observer.

Study Groups

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Group C

conventional two-operator axillary brachial plexus blockage

Group Type ACTIVE_COMPARATOR

conventional two-operator versus single operator using Jedi grip axillary brachial plexus blockage

Intervention Type PROCEDURE

on goup C, operator used the probe and needle with different hands while an assistant controlling the syringe to aspirate or inject local anesthetic. On Group J 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.

Group J

axillary brachial plexus block with single operator using Jedi grip

Group Type ACTIVE_COMPARATOR

conventional two-operator versus single operator using Jedi grip axillary brachial plexus blockage

Intervention Type PROCEDURE

on goup C, operator used the probe and needle with different hands while an assistant controlling the syringe to aspirate or inject local anesthetic. On Group J 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.

Interventions

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conventional two-operator versus single operator using Jedi grip axillary brachial plexus blockage

on goup C, operator used the probe and needle with different hands while an assistant controlling the syringe to aspirate or inject local anesthetic. On Group J 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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 and prior surgery in the axillary regions.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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ismail aytaç

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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İsmail Aytac

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

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Ankara City Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 21831086 (View on PubMed)

Other Identifiers

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E-18-1955

Identifier Type: -

Identifier Source: org_study_id

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