- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04487366
Single and Double Operator Techniques in Ultrasound-guided Peripheral Nerve Block Learning Curve
Comparison of Single and Double Operator Techniques in Ultrasound-guided Peripheral Nerve Block Learning Curve for Anesthesia Residency Training on a Gelatin-based Phantom Model: a Prospective Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Ultrasound-guided peripheral blocks are conventionaly performed by double operators. One operator controls both the ultrasound probe and peripheric block needle. Another assistant operator aspirate or injects local anesthetic. In this technique operator do not sense resistance in the syringe. Also this technique requires a well-done communication and coordination between operators.
In order to eliminate disadvantages of this technique several single-operator grip techniques of the needle and syringe have been described(1- Jedi grip: Pappin and Christie/ 2- Bedforth/ 3- on lock: Gupta and Berrill). Single operator techniques allow the provider to perform independently.
Aim of this study is to compare learning curves of single and double operator ultrasound-guided peripheric nerve block techniques on a home-made gelatin-based phantom model.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey, 06600
- Ankara City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- To be a junior resident of anesthesiology(< 2 years )
Exclusion Criteria:
- Refusal of resident
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Double Operator Ultrasound-Guided Regional Anesthesia
resident control block needle and ultrasound probe and asistant operator inject the solution.
resident reach the target area created in the phantom model using a block needle with ultrasound guidance
|
resident reach the targeted area on the phantom model using ultrasoun guidance and independently or with asistance inject the solution
|
Active Comparator: Jedi Grip
resident control block needle, ultrasound probe and syringe independently with jedi grip; reach the target area created in the phantom model using a block needle with ultrasound guidance; inject and aspirate the solution.
|
resident reach the targeted area on the phantom model using ultrasoun guidance and independently or with asistance inject the solution
|
Active Comparator: On-lock grip
resident control block needle, ultrasound probe and syringe independently with on-lock grip; reach the target area created in the phantom model using a block needle with ultrasound guidance; inject the solution.
|
resident reach the targeted area on the phantom model using ultrasoun guidance and independently or with asistance inject the solution
|
Active Comparator: Bedforth alternative grip
resident control block needle, ultrasound probe and syringe independently with bedforth's alternative grip; reach the target area created in the phantom model using a block needle with ultrasound guidance; inject the solution.
|
resident reach the targeted area on the phantom model using ultrasoun guidance and independently or with asistance inject the solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to correct grip1
Time Frame: during implementation of procedure on phantom model(first session)
|
Time(sec) from start command to correct grip of the probe, needle and syringe for each technique
|
during implementation of procedure on phantom model(first session)
|
image quality1
Time Frame: during implementation of procedure on phantom model(first session)
|
provided image quality by resident for each technique which is assessed by investigator by four point Liker Scale( 1- much worse 2- worse 3- better 4- much better)
|
during implementation of procedure on phantom model(first session)
|
number of attempts1
Time Frame: during implementation of procedure on phantom model(first session)
|
number of attempts until correct needling to target area
|
during implementation of procedure on phantom model(first session)
|
needling time 1
Time Frame: during implementation of procedure on phantom model(first session)
|
time to reach target area with block needle
|
during implementation of procedure on phantom model(first session)
|
success of injection1
Time Frame: during implementation of procedure on phantom model(first session)
|
successful if injected water flows from hose of model/ unsuccessful if solution do not flow
|
during implementation of procedure on phantom model(first session)
|
Time to correct grip2
Time Frame: during implementation of procedure on phantom model(second session)
|
Time(sec) from start command to correct grip of the probe, needle and syringe for each technique
|
during implementation of procedure on phantom model(second session)
|
Time to correct grip3
Time Frame: during implementation of procedure on phantom model(third session)
|
Time(sec) from start command to correct grip of the probe, needle and syringe for each technique
|
during implementation of procedure on phantom model(third session)
|
image quality2
Time Frame: during implementation of procedure on phantom model(second session)
|
provided image quality by resident for each technique which is assessed by investigator by four point Liker Scale( 1- much worse 2- worse 3- better 4- much better)
|
during implementation of procedure on phantom model(second session)
|
image quality3
Time Frame: during implementation of procedure on phantom model(third session)
|
provided image quality by resident for each technique which is assessed by investigator by four point Liker Scale( 1- much worse 2- worse 3- better 4- much better)
|
during implementation of procedure on phantom model(third session)
|
number of attempts2
Time Frame: during implementation of procedure on phantom model(second session)
|
number of attempts until correct needling to target area
|
during implementation of procedure on phantom model(second session)
|
number of attempts3
Time Frame: during implementation of procedure on phantom model(third session)
|
number of attempts until correct needling to target area
|
during implementation of procedure on phantom model(third session)
|
needling time 2
Time Frame: during implementation of procedure on phantom model(second session)
|
time to reach target area with block needle
|
during implementation of procedure on phantom model(second session)
|
needling time 3
Time Frame: during implementation of procedure on phantom model(third session)
|
time to reach target area with block needle
|
during implementation of procedure on phantom model(third session)
|
success of injection2
Time Frame: during implementation of procedure on phantom model(second session)
|
successful if injected water flows from hose of model/ unsuccessful if solution do not flow
|
during implementation of procedure on phantom model(second session)
|
success of injection3
Time Frame: during implementation of procedure on phantom model(third session)
|
successful if injected water flows from hose of model/ unsuccessful if solution do not flow
|
during implementation of procedure on phantom model(third session)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NASA-TLX (NASA Task Load Index)
Time Frame: during implementation of procedure on phantom model(third session)
|
Resident assessment of each techniques for Mental Demand ,Physical Demand, Temporal Demand, Performance, Effort and Frustration
|
during implementation of procedure on phantom model(third session)
|
Assesment of education
Time Frame: during education of techniques
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Residents assesment of pre-procedural education with a questtionarie. "Education was sufficient enough to safely perform peripheral block":
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during education of techniques
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: İsmail Aytac, Ankara City Hospital Anesthesiology Department
Publications and helpful links
General 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.
- Gupta P, Berrill A. 'On lock' - a further single-operator ultrasound-guided regional anaesthesia grip. Anaesthesia. 2017 Oct;72(10):1289. doi: 10.1111/anae.14050. No abstract available.
- Bedforth N, Townsley P, Maybin J, Eisenberg E. Single-handed ultrasound-guided regional anaesthesia. Anaesthesia. 2011 Sep;66(9):846. doi: 10.1111/j.1365-2044.2011.06864.x. No abstract available.
- Miyake S. Factors influencing mental workload indexes. J UOEH. 1997 Dec 1;19(4):313-25. doi: 10.7888/juoeh.19.313.
- Guven Aytac B, Unal S, Aytac I. A randomized, controlled simulation study comparing single and double operator ultrasound-guided regional nerve block techniques using a gelatine-based home-made phantom. Medicine (Baltimore). 2022 Sep 2;101(35):e30368. doi: 10.1097/MD.0000000000030370.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E1/20-804
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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