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

Brachial Plexus Block Clinical Trial

Official title:

Is Jedi Grip Efficient And Effective In Ultrasound Guided Peripheral Nerve Block: A Prospective, Randomized, Observer-Blinded Comparison Between Single And Double Operator Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04463329
• Other study ID #: E-18-1955
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: July 2020
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 28, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brachial Plexus Block
• Ultrasound, Interventional

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	block performance time	the sum of imaging and needling times	during procedure
Primary	success rate	patients percentage with provided successful anesthesia	during operation
Secondary	Onset time of sensory block	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).	before operation
Secondary	Onset time of motor block	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.[	before operation