NCT04748211

Brief Summary

to research the oxygenitaon effects of infraclavicular and interscalene blocks on the forearm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

December 13, 2020

Last Update Submit

February 10, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • oxygenation of the forearm

    to compare the oxygenation of the forearm by measuring perfusion index device

    during the procedure three times

Study Arms (2)

Infraclavicular Block

EXPERIMENTAL

Group I received USG and neurostimulator guided infraclavicular block, 10 ml 2% lidocain and 10 ml 0.05% marcaine was administered for local anetshesia. After the block was administered MAP, HR, TAV, BAD, BAA, BF, PI and rSO 2 values were measured and recorded at the 10th, 20th, and 30th minutes.

Procedure: Infraclavicular Block

Interscalen Block

EXPERIMENTAL

Group II received USG and neurostimulator guided interscalen block. 10 ml 2% lidocain and 10 ml 0.05% marcaine was administered for local anetshesia. After the block was administered MAP, HR, TAV, BAD, BAA, BF, PI and rSO 2 values were measured and recorded at the 10th, 20th, and 30th minutes.

Procedure: Interscalen Block

Interventions

USI and neurostimulator guided infraclavicular block, 10 ml 2% lidocain and 10 ml 0.05% marcaine was administered for local anetshesia. After the block was administered MAP, HR, TAV, BAD, BAA, BF, PI and rSO 2 values were measured and recorded at the 10th, 20th, and 30th minutes.

Infraclavicular Block

USI and neurostimulator guided interscalen block, 10 ml 2% lidocain and 10 ml 0.05% marcaine was administered for local anetshesia. After the block was administered MAP, HR, TAV, BAD, BAA, BF, PI and rSO 2 values were measured and recorded at the 10th, 20th, and 30th minutes.

Interscalen Block

Eligibility Criteria

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

You may qualify if:

  • aged between 18-65
  • ASA Score I-III
  • undergoing elective or emergency arm, elbow and forearm surgery

You may not qualify if:

  • Patient's refusal for Brachial Plexus Blockage
  • Patients who had any neurological disorders preventing the evaluation of the sensory block in the upper extremity,
  • Infection in the area to be blocked with ICB or ISB,
  • Non-cooperated patients
  • Patients with coagulopathy,
  • Morbidly obese patients
  • Patients with diabetes mellitus
  • Patients with hypertension
  • Patients with peripheral artery disease
  • Patients with allergy to the drugsto be used
  • Patients who had trauma in the area scheduled for the block
  • Paitens who had deterioration of anatomical integrity because of previous surgery
  • Pregnant women
  • Patients whose block failed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bulent Ecevit University

Zonguldak, Turkey (Türkiye)

Location

Study Officials

  • Eren Açıkgöz, M.D.

    Bulent Ecevit University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study will be a two-arm parallel assignment. One group will receive infraclavicular block and the other will receive interscalen block
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

December 13, 2020

First Posted

February 10, 2021

Study Start

June 15, 2018

Primary Completion

June 15, 2019

Study Completion

June 15, 2019

Last Updated

February 12, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations