NCT04471025

Brief Summary

The investigators aimed to compare the block characteristics of the single operator "jedi grip" technique and the conventional double operator technique.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

12 months

First QC Date

July 4, 2020

Last Update Submit

July 13, 2020

Conditions

Keywords

Jedi GripUltrasound guided infraclavicular block

Outcome Measures

Primary Outcomes (2)

  • block performance time

    teh sum of imaging and needling time

    during block application

  • block success

    incidence of ( %) surgery with successful anesthesia

    during surgery

Secondary Outcomes (2)

  • Sensory block onset time

    before surgery

  • motor block onset time

    before surgery

Study Arms (2)

Group I

ACTIVE COMPARATOR

USG guided infraclavicular block with single operator jedi grip technique

Procedure: USG guided infraclavicular block

Group 2

ACTIVE COMPARATOR

USG guided infraclavicular block with conventional double operator technique

Procedure: USG guided infraclavicular block

Interventions

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.

Group 2Group I

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergoing elective hand, wrist and forearm surgery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, 06600, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 21831086BACKGROUND

Study Officials

  • İsmail Aytac

    Ankara City Hospital Anesthesiology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
After completion of the block, a single blinded observer recorded demographic data and evaluated the block characteristics
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: single-center, prospective, randomized into two goups: Jedi grip versus conventional double operator technique
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

July 4, 2020

First Posted

July 14, 2020

Study Start

May 14, 2018

Primary Completion

May 3, 2019

Study Completion

May 3, 2019

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations