Effect of Infraclavicular and Interscalen Block on Oxygenitaon of the Forearm

Effect of Infraclavicular and Interscalen Block on Oxygenitaon of the Forearm : Randomized Controlled Study.

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

Study Overview

• Status: Completed
• Conditions: Upper Extremity Fracture
• Intervention / Treatment: Procedure: Infraclavicular Block; Procedure: Interscalen Block

Detailed Description

To research the oxygenation effects of infraclavicular and interscalen blocks on the forearm by comparing the blood flow (BF) values using the USG, Perfusion index (PI) and Near infrared spectroscopy (NIRS) values using the massimo device.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Zonguldak, Turkey
    • Zonguldak Bulent Ecevit University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infraclavicular Block; 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; 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.
Experimental: Interscalen Block; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygenation of the forearm	to compare the oxygenation of the forearm by measuring perfusion index device	during the procedure three times

Collaborators and Investigators

• Sponsor: Bulent Ecevit University
• Investigators: Principal Investigator: Eren Açıkgöz, M.D., Bulent Ecevit University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Actual): June 15, 2019
• Study Completion (Actual): June 15, 2019

Study Registration Dates

• First Submitted: December 13, 2020
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2017-116-06/12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No