Is Jedi Grip Efficient And Effective In Ultrasound Guided Peripheral Nerve Block: A Prospective, Randomized, Observer-Blinded Comparison Between Single And Double Operator Technique
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ankara City Hospital Bilkent
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- success rate
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Group C
conventional two-operator axillary brachial plexus blockage
Intervention: conventional two-operator versus single operator using Jedi grip axillary brachial plexus blockage (Procedure)
Group J
axillary brachial plexus block with single operator using Jedi grip
Intervention: conventional two-operator versus single operator using Jedi grip axillary brachial plexus blockage (Procedure)
Outcomes
Primary Outcomes
success rate
Time Frame: during operation
patients percentage with provided successful anesthesia
block performance time
Time Frame: during procedure
the sum of imaging and needling times
Secondary Outcomes
- Onset time of sensory block(before operation)
- Onset time of motor block(before operation)
Investigators
ismail aytaç
Principal Investigator
Ankara City Hospital Bilkent