Single and Double Operator Techniques in Ultrasound-guided Peripheral Nerve Block Learning Curve

Sponsor
Ankara City Hospital Bilkent (Other)
Overall Status
Unknown status
CT.gov ID
NCT04487366
Collaborator
(none)
50
1
4
3
16.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: reaching targeted area on the phantom model
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
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
Actual Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Sep 15, 2020
Anticipated Study Completion Date :
Oct 1, 2020

Arms and Interventions

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

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

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.

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

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.

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

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.

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

Outcome Measures

Primary Outcome Measures

  1. Time to correct grip1 [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

  2. image quality1 [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)

  3. number of attempts1 [during implementation of procedure on phantom model(first session)]

    number of attempts until correct needling to target area

  4. needling time 1 [during implementation of procedure on phantom model(first session)]

    time to reach target area with block needle

  5. success of injection1 [during implementation of procedure on phantom model(first session)]

    successful if injected water flows from hose of model/ unsuccessful if solution do not flow

  6. Time to correct grip2 [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

  7. Time to correct grip3 [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

  8. image quality2 [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)

  9. image quality3 [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)

  10. number of attempts2 [during implementation of procedure on phantom model(second session)]

    number of attempts until correct needling to target area

  11. number of attempts3 [during implementation of procedure on phantom model(third session)]

    number of attempts until correct needling to target area

  12. needling time 2 [during implementation of procedure on phantom model(second session)]

    time to reach target area with block needle

  13. needling time 3 [during implementation of procedure on phantom model(third session)]

    time to reach target area with block needle

  14. success of injection2 [during implementation of procedure on phantom model(second session)]

    successful if injected water flows from hose of model/ unsuccessful if solution do not flow

  15. success of injection3 [during implementation of procedure on phantom model(third session)]

    successful if injected water flows from hose of model/ unsuccessful if solution do not flow

Secondary Outcome Measures

  1. NASA-TLX (NASA Task Load Index) [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

  2. Assesment of education [during education of techniques]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
24 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • To be a junior resident of anesthesiology(< 2 years )
Exclusion Criteria:
  • Refusal of resident

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara City Hospital Ankara Turkey 06600

Sponsors and Collaborators

  • Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: İsmail Aytac, Ankara City Hospital Anesthesiology Department

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
ismail aytaç, Principal Investigator, Ankara City Hospital Bilkent
ClinicalTrials.gov Identifier:
NCT04487366
Other Study ID Numbers:
  • E1/20-804
First Posted:
Jul 27, 2020
Last Update Posted:
Jul 27, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ismail aytaç, Principal Investigator, Ankara City Hospital Bilkent
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2020