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

NCT04463329 | Completed

• 1 other identifier: E-18-1955
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brachial Plexus Block; Ultrasound, Interventional

Keywords

Brachial Plexus Block, Ultrasound-Guided, Jedi Grip, Double operator peripheric nerve block

Outcome Measures

Primary Outcomes (2)

• block performance time

  the sum of imaging and needling times

  during procedure

• success rate

  patients percentage with provided successful anesthesia

  during operation

Secondary Outcomes (2)

• Onset time of sensory block

  before operation

• Onset time of motor block

  before operation

Study Arms (2)

Group C

ACTIVE COMPARATOR

conventional two-operator axillary brachial plexus blockage

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

Group J

ACTIVE COMPARATOR

axillary brachial plexus block with single operator using Jedi grip

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

Interventions

conventional two-operator versus single operator using Jedi grip axillary brachial plexus blockage 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 C; Group J

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing elective hand, wrist and forearm surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06600, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 21831086 BACKGROUND

Study Officials

• İsmail Aytac

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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)

Study Record Dates

• First Submitted: July 4, 2020
• First Posted: July 9, 2020
• Study Start: May 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 28, 2019
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)