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Clinical Trials/NCT04471025
NCT04471025CompletedNot Applicable

A Prospective, Randomized, Observer-Blinded Comparison Between Single And Double Operator In Ultrasound Guided Infraclavicular Block: Jedi Grip Versus Conventional Double Operator Technique

Ankara City Hospital Bilkent2 sites in 1 country78 target enrollmentStarted: May 14, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
78
Locations
2
Primary Endpoint
block performance time

Study Overview

Brief Summary

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Masking Description

After completion of the block, a single blinded observer recorded demographic data and evaluated the block characteristics

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • undergoing elective hand, wrist and forearm surgery

Exclusion Criteria

  • hepatic or renal failure
  • serious cardiac or pulmoner disease
  • local or systemic infection
  • 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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • motor block onset time(before surgery)
  • Sensory block onset time(before surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

ismail aytaç

assistant professor

Ankara City Hospital Bilkent

Study Sites (2)

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