UltrasoundNCT04471025
Jedi Grip Versus Double Operator Technique For Ultrasound Guided Infraclavicular Block
A study testing USG guided infraclavicular block in people with Ultrasound and Nerve Block, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to compare the block characteristics of the single operator "jedi grip" technique and the conventional double operator technique. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ultrasound, Nerve Block
- What is being tested?
- USG guided infraclavicular block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 May 2018to 3 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing elective hand, wrist and forearm surgery
Who cannot join
- hepatic or renal failure
- serious cardiac or pulmoner disease
- local or systemic infection
- sepsis
- coagulation disorder
- neurological, muscular or psychiatric disease
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Observer-Blinded Comparison Between Single And Double Operator In Ultrasound Guided Infraclavicular Block: Jedi Grip Versus Conventional Double Operator Technique
The investigators aimed to compare the block characteristics of the single operator "jedi grip" technique and the conventional double operator technique.
Read the detailed description
Patients undergoing hand, wrist, elbow and forearm surgery randomly assigned two groups (Group I: Jedi grip and Group II: Conventional double operator technique). By a blind observer, the block characteristics were evaluated and recorded .
- Conditions
- Ultrasound, Nerve Block
- Being tested
- USG guided infraclavicular block
- Keywords
- Jedi Grip, Ultrasound guided infraclavicular block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USG guided infraclavicular blockProcedure or surgery
USG guided infraclavicular block was applied to patients either by conventional two-person technique or by one person Jedi technique according to the allocated group. On Group I 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. On Group II, operator used the probe and needle with different hands while an assistant controlling the syringe to aspirate or inject local anesthetic.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | USG guided infraclavicular block with single operator jedi grip technique Receives: Procedure: USG guided infraclavicular block |
| Group 2 | Active comparator | USG guided infraclavicular block with conventional double operator technique Receives: Procedure: USG guided infraclavicular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
block performance time
teh sum of imaging and needling time
Measured: during block application
block success
incidence of ( %) surgery with successful anesthesia
Measured: during surgery
Secondary outcomes (2)
Sensory block onset time
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 a previously validated 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)
Measured: before surgery
motor block onset time
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 (validated) 3-point scale: 0 = no block, 1 = paresis and 2 = paralysis.
Measured: before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start14 May 2018
- Primary completion3 May 2019
- Study completion3 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-center, prospective, randomized into two goups: Jedi grip versus conventional double operator technique
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ismail aytaç, Ankara City Hospital Bilkent
- Investigators
- İsmail Aytac, Principal investigator, Ankara City Hospital Anesthesiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471025
- Sponsor's protocol ID
- E-18-1935
- Status last verified
- Jul 2020
- First submitted
- 4 Jul 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21831086
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Observer-Blinded Comparison Between Single And Double Operator In Ultrasound Guided Infraclavicular Block: Jedi Grip Versus Conventional Double Operator Technique
- ClinicalTrials.gov ID
- NCT04471025
- Acronym / sponsor ID
- E-18-1935
- Conditions
- Ultrasound, Nerve Block
- Keywords
- Jedi Grip, Ultrasound guided infraclavicular block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 14 May 2018 (actual)
- Primary completion
- 3 May 2019 (actual)
- Study completion
- 3 May 2019 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aimed to compare the block characteristics of the single operator "jedi grip" technique and the conventional double operator technique.
Detailed description
Patients undergoing hand, wrist, elbow and forearm surgery randomly assigned two groups (Group I: Jedi grip and Group II: Conventional double operator technique). By a blind observer, the block characteristics were evaluated and recorded .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- single-center, prospective, randomized into two goups: Jedi grip versus conventional double operator technique
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Procedure: USG guided infraclavicular blockUSG guided infraclavicular block with single operator jedi grip technique |
| Group 2 | Active comparator | Procedure: USG guided infraclavicular blockUSG guided infraclavicular block with conventional double operator technique |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing elective hand, wrist and forearm surgery
Key exclusion criteria (13 listed)
- hepatic or renal failure
- serious cardiac or pulmoner disease
- local or systemic infection
- sepsis
- coagulation disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| USG guided infraclavicular blockUSG guided infraclavicular block was applied to patients either by conventional two-person technique or by one person Jedi technique according to the allocated group. On Group I 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. On Group II, operator used the probe and needle with different hands while an assistant controlling the syringe to aspirate or inject local anesthetic. | Procedure or surgery | Group 2, Group I |
Primary outcome
block performance time
Time frame: during block application
teh sum of imaging and needling time
block success
Time frame: during surgery
incidence of ( %) surgery with successful anesthesia
2 secondary outcomes
Sensory block onset time
Time frame: before surgery
motor block onset time
Time frame: before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Background: PubMed 21831086Pappin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İsmail Aytac principal investigator
Ankara City Hospital Anesthesiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing USG guided infraclavicular block in people with Ultrasound and Nerve Block, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
block performance time (time frame: during block application). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04471025, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.