Clinical trial NCT04463329: Jedi Grip vs. Double Operator Technique for Axillary Brachial Plexus Block
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brachial Plexus Block
Ultrasound, Interventional
Keywords: Brachial Plexus Block, Ultrasound-Guided, Jedi Grip, Double operator peripheric nerve block
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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.

Primary outcomes:
measure: block performance time
timeFrame: during procedure
measure: success rate
timeFrame: during operation
Secondary outcomes:
measure: Onset time of sensory block
timeFrame: before operation
measure: Onset time of motor block
timeFrame: before operation
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: İsmail Aytac
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.