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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04487366
Other study ID # E1/20-804
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date October 1, 2020

Study information

Verified date July 2020
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aim of this study is to compare learning curves of single(1- Jedi grip: Pappin and Christie/ 2- Bedforth/ 3- on lock: Gupta and Berrill) and double operator ultrasound-guided peripheric nerve block techniques on a home-made gelatin-based phantom model.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 50
Est. completion date October 1, 2020
Est. primary completion date September 15, 2020
Accepts healthy volunteers No
Gender All
Age group 24 Years to 40 Years
Eligibility Inclusion Criteria:

- To be a junior resident of anesthesiology(< 2 years )

Exclusion Criteria:

- Refusal of resident

Study Design


Related Conditions & MeSH terms


Intervention

Other:
reaching targeted area on the phantom model
resident reach the targeted area on the phantom model using ultrasoun guidance and independently or with asistance inject the solution

Locations

Country Name City State
Turkey Ankara City Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

Miyake S. Factors influencing mental workload indexes. J UOEH. 1997 Dec 1;19(4):313-25. Review. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time to correct grip1 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)
Primary image quality1 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)
Primary number of attempts1 number of attempts until correct needling to target area during implementation of procedure on phantom model(first session)
Primary needling time 1 time to reach target area with block needle during implementation of procedure on phantom model(first session)
Primary success of injection1 successful if injected water flows from hose of model/ unsuccessful if solution do not flow during implementation of procedure on phantom model(first session)
Primary Time to correct grip2 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)
Primary Time to correct grip3 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)
Primary image quality2 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)
Primary image quality3 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)
Primary number of attempts2 number of attempts until correct needling to target area during implementation of procedure on phantom model(second session)
Primary number of attempts3 number of attempts until correct needling to target area during implementation of procedure on phantom model(third session)
Primary needling time 2 time to reach target area with block needle during implementation of procedure on phantom model(second session)
Primary needling time 3 time to reach target area with block needle during implementation of procedure on phantom model(third session)
Primary success of injection2 successful if injected water flows from hose of model/ unsuccessful if solution do not flow during implementation of procedure on phantom model(second session)
Primary success of injection3 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 NASA-TLX (NASA Task Load Index) 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)
Secondary Assesment of education Residents assesment of pre-procedural education with a questtionarie. "Education was sufficient enough to safely perform peripheral block":
I absolutely agree
I approve
I am indecisive
I do not approve
Absolutely Disagree
during education of techniques
See also
  Status Clinical Trial Phase
Terminated NCT01965314 - A Trial to Determine the Effect of Simulation Based Training on Initial Performance of Ultrasound Guided Axillary Brachial Plexus Blockade in a Clinical Setting N/A