- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04463329
Jedi Grip vs. Double Operator Technique for Axillary Brachial Plexus Block
July 17, 2020 updated by: ismail aytaç, Ankara City Hospital Bilkent
Is Jedi Grip Efficient And Effective In Ultrasound Guided Peripheral Nerve Block: A Prospective, Randomized, Observer-Blinded Comparison Between Single And Double Operator Technique
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey, 06600
- Ankara City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group C
conventional two-operator 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.
|
|
Active Comparator: Group J
axillary brachial plexus block with single operator using Jedi grip
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
block performance time
Time Frame: during procedure
|
the sum of imaging and needling times
|
during procedure
|
|
success rate
Time Frame: during operation
|
patients percentage with provided successful anesthesia
|
during operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Onset time of sensory block
Time Frame: 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).
|
before operation
|
|
Onset time of motor block
Time Frame: 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.[
|
before operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: İsmail Aytac, Ankara City Hospital Bilkent
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2018
Primary Completion (Actual)
February 1, 2019
Study Completion (Actual)
February 28, 2019
Study Registration Dates
First Submitted
July 4, 2020
First Submitted That Met QC Criteria
July 8, 2020
First Posted (Actual)
July 9, 2020
Study Record Updates
Last Update Posted (Actual)
July 21, 2020
Last Update Submitted That Met QC Criteria
July 17, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E-18-1955
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Brachial Plexus Block
-
Diskapi Yildirim Beyazit Education and Research...CompletedBrachial Plexus BlockTurkey
-
University of MalayaCompletedBrachial Plexus Block
-
Sohag UniversityNot yet recruitingBrachial Plexus Block
-
Sohag UniversityCompleted
-
Huazhong University of Science and TechnologyUnknown
-
Diakonhjemmet HospitalCompleted
-
B.P. Koirala Institute of Health SciencesCompleted
-
University Hospital, AntwerpCompletedSurgery | Anesthesia | Brachial Plexus Block | Nerve BlockBelgium
-
Sohag UniversityNot yet recruiting
-
Kasr El Aini HospitalRecruiting