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

Not Applicable

Completed

• Conditions: Brachial Plexus Block; Ultrasound, Interventional
• Interventions: Procedure: conventional two-operator versus single operator using Jedi grip axillary brachial plexus blockage

• Registration Number: NCT04463329
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Detailed Description

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).

Study Timeline

• Study Start: 2018-05-01
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-28
• Status Verified: 2020-07
• Study First Submitted: 2020-07-04
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-09
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	conventional two-operator versus single operator using Jedi grip axillary brachial plexus blockage	conventional two-operator axillary brachial plexus blockage
Group J	conventional two-operator versus single operator using Jedi grip axillary brachial plexus blockage	axillary brachial plexus block with single operator using Jedi grip

Primary Outcome Measures

Name	Time	Method
success rate	during operation	patients percentage with provided successful anesthesia
block performance time	during procedure	the sum of imaging and needling times

Secondary Outcome Measures

Name	Time	Method
Onset time of sensory block	before operation	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 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).
Onset time of motor block	before operation	Motor 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 3-point scale: 0 = no block, 1 = paresis and 2 = paralysis.\[

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Turkey