The Use of NIRS in Brachial Plexus Block
Primary Purpose
Arterio-venous Fistula
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Near infrared spectroscopy
Sponsored by
About this trial
This is an interventional basic science trial for Arterio-venous Fistula
Eligibility Criteria
Inclusion Criteria:
- ASA I-III,
- chronic renal failure and needing arteriovenous fistula surgery
Exclusion Criteria:
- hemoglobinopathy
- coagulopathy,
- wound or infection in the thenar eminence
- wound and infection in the supraclavicular region on the side of the regional block
- allergic to local anesthetic drugs
- mental retardation
Sites / Locations
- Medeniyet University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Brachial plexus blockage group
local anesthesia group
Arm Description
Outcomes
Primary Outcome Measures
improvement of tissue oxygenation
Improvemen of tissue oxygenation by different anesthetic technique
Secondary Outcome Measures
primary patency of arteriovenous fistula
Patients will called after one month later from surgery.
Full Information
NCT ID
NCT04177901
First Posted
November 20, 2019
Last Updated
February 3, 2022
Sponsor
Istanbul Medeniyet University
1. Study Identification
Unique Protocol Identification Number
NCT04177901
Brief Title
The Use of NIRS in Brachial Plexus Block
Official Title
The Use of NIRS of Monitorization in Arteriovenous Fistule Surgery With Brachial Plexus Block or Local Infiltration Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 10, 2019 (Actual)
Primary Completion Date
July 10, 2020 (Actual)
Study Completion Date
July 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study is planed on ASA I-III, 18-80 years old 60 patients developing chronic renal failure and needing arteriovenous fistula surgery for dialysis program in Istanbul Medeniyet University Goztepe Research Hospital. Informed consent of the patients will be obtained before surgery.Patients with hemoglobinopathy, coagulopathy, wound or infection in the thenar eminence, wound and infection in the supraclavicular region on the side of the regional block, allergic to local anesthetic drugs and mental retardation will not be included in the study.
Standart monitorization (ECG, peripheral oxygen saturation and non-invasive arterial pressure monitoring) will be made. Base and 5 minutes interval values will be recorded until the end of the surgery. The pads of the NIRS monitor will be placed on the thenar eminence of both hands and fixed with the help of a draipe and basal measurements will be taken and recorded. The patients will then be divided into two groups according to computer-generated table of random numbers.
Group L patients will undergo surgical cleansing and sterile draping and infiltrate %5 bupivacaine 15ml. Group B the supraclavicular areas of the patients who will undergo surgical procedures will be sterile covered after appropriate sterilization. After the brachial plexus is visualized around the subclavian artery in the supraclavicular region with the help of Samsung ultrasound device, Bupivacaine 5% 20ml and Lidocaine 2% 10ml will be applied around the brachial plexus using a 50mm stimuplex needle. The effectiveness of the block will be evaluated by a single investigator after withdrawal of the needle, either by effective anesthesia with the block or every 10 minutes up to 30 minutes. The sensory block will be evaluated with a 3 point scale and the motor block will be evaluated routinely before and after the modified bromage scale (scored between 0 and 4). After withdrawal of the treated needle, we will contact the relevant nerve dermatome with cold application (cold SF) and ask the patient to classify the degree of cold feeling from 0 to 3. Block will be considered unsuccessful if surgical block cannot be provided after 30 minutes or if the patient experiences pain at any time during the operation. The duration of anesthesia occurring after local infiltration of Group L and the sensory and motor blockade after group B stimulation is taken will be recorded. In both groups, NIRS values will be recorded at 5 minute intervals until the end of the case after local anesthetic application.
Investigator will call the patients for primer patency of fistula one month after operation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterio-venous Fistula
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brachial plexus blockage group
Arm Type
Active Comparator
Arm Title
local anesthesia group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Near infrared spectroscopy
Intervention Description
It is used for detection of tissue oxygenation
Primary Outcome Measure Information:
Title
improvement of tissue oxygenation
Description
Improvemen of tissue oxygenation by different anesthetic technique
Time Frame
85 minutes
Secondary Outcome Measure Information:
Title
primary patency of arteriovenous fistula
Description
Patients will called after one month later from surgery.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I-III,
chronic renal failure and needing arteriovenous fistula surgery
Exclusion Criteria:
hemoglobinopathy
coagulopathy,
wound or infection in the thenar eminence
wound and infection in the supraclavicular region on the side of the regional block
allergic to local anesthetic drugs
mental retardation
Facility Information:
Facility Name
Medeniyet University
City
İ̇stanbul
ZIP/Postal Code
34887
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Use of NIRS in Brachial Plexus Block
We'll reach out to this number within 24 hrs