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Is Perfusion Index an Indicator of Block Success in Ultrasound-guided Infraclavicular Brachial Plexus Block

Primary Purpose

Carpal Tunnel Syndrome, Perfusion Index

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Infraclavicular nerve block
Without nerve block
Sponsored by
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Carpal Tunnel Syndrome focused on measuring Infraclavicular block, Perfusion index, Ultrasonography, Block assessment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages of 18-75
  • Patients who will diagnose with carpal tunnel syndrome by electroneuromyography (ENMG), and will undergo unilateral surgery under elective conditions
  • ASA I-II-III patients

Exclusion Criteria:

  • Patients who will refuse this method
  • Neurological deficits,
  • Diabetes mellitus,
  • Local anesthetic allergy,
  • Morbidly obese,
  • Peripheral vascular disease, coronary artery disease, or coagulopathy

Sites / Locations

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Blocked arm

Unblocked arm

Arm Description

The investigators performed an infraclavicular nerve block to the operated arm group to provide anesthesia.

The upper extremity without block was assigned as the control group, and a comparison was made between the two upper extremities.

Outcomes

Primary Outcome Measures

Evaluation of whether perfusion index is a reliable and objective method to indicate block success
Perfusion index was measured up to 6 hours after the procedure.

Secondary Outcome Measures

Determining of a cut-off value for PI and PI ratio for a successful block.
There may be changes in the cut-off value depending on the applied plexus area, local anesthesia, volume and concentration of LA and the applied assistive technique (ultrasound or nerve stimulator). For both this reason and due to the high variability in the PI values, the PI ratio was calculated to predict block success.

Full Information

First Posted
June 1, 2021
Last Updated
June 4, 2021
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04921891
Brief Title
Is Perfusion Index an Indicator of Block Success in Ultrasound-guided Infraclavicular Brachial Plexus Block
Official Title
Comparison of Block Success in Patients Undergoing Ultrasound-guided Infraclavicular Brachial Plexus Block With Bilateral Upper Extremity Perfusion Index
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 15, 2014 (Actual)
Primary Completion Date
April 15, 2014 (Actual)
Study Completion Date
October 30, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The infraclavicular nerve block, which is frequently preferred in upper extremity surgeries, provides additional advantages such as reduction in opioid consumption by providing analgesic effect in the postoperative period as welll. The success of peripheral nerve blocks is usually assessed by subjective feedback from the patient, and patient cooperation is needed. The aim of this study is to assess whether the perfusion index level, which can be measured noninvasively, can be a predictor of the infraclavicular block success.
Detailed Description
Thirty patients who were operated on for carpal tunnel syndrome under infraclavicular brachial plexus block were included in our study. After the procedure, at 10-minute intervals, the sensory block was assessed by a pinprick test, and the motor block was assessed by the ability to flex the hand and the forearm. In addition, PI and skin temperature were measured 0-10-20-30 minutes after the block and at postoperative 2, 4, and 6 hours. 30 minutes after the measurements, the surgical procedure was allowed to begin in patients with successful block.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Perfusion Index
Keywords
Infraclavicular block, Perfusion index, Ultrasonography, Block assessment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blocked arm
Arm Type
Active Comparator
Arm Description
The investigators performed an infraclavicular nerve block to the operated arm group to provide anesthesia.
Arm Title
Unblocked arm
Arm Type
Active Comparator
Arm Description
The upper extremity without block was assigned as the control group, and a comparison was made between the two upper extremities.
Intervention Type
Procedure
Intervention Name(s)
Infraclavicular nerve block
Intervention Description
The investigators performed an infraclavicular nerve block to the operated arm group to provide anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Without nerve block
Intervention Description
The upper extremity without block was assigned as the control group, and a comparison was made between the two upper extremities.
Primary Outcome Measure Information:
Title
Evaluation of whether perfusion index is a reliable and objective method to indicate block success
Description
Perfusion index was measured up to 6 hours after the procedure.
Time Frame
6 hours postprocedurly
Secondary Outcome Measure Information:
Title
Determining of a cut-off value for PI and PI ratio for a successful block.
Description
There may be changes in the cut-off value depending on the applied plexus area, local anesthesia, volume and concentration of LA and the applied assistive technique (ultrasound or nerve stimulator). For both this reason and due to the high variability in the PI values, the PI ratio was calculated to predict block success.
Time Frame
Up to 6 hours after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages of 18-75 Patients who will diagnose with carpal tunnel syndrome by electroneuromyography (ENMG), and will undergo unilateral surgery under elective conditions ASA I-II-III patients Exclusion Criteria: Patients who will refuse this method Neurological deficits, Diabetes mellitus, Local anesthetic allergy, Morbidly obese, Peripheral vascular disease, coronary artery disease, or coagulopathy
Facility Information:
Facility Name
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
City
Istanbul
State/Province
Bakirkoy
ZIP/Postal Code
34147
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Is Perfusion Index an Indicator of Block Success in Ultrasound-guided Infraclavicular Brachial Plexus Block

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