Prediction of Clinical Outcome in Axillary Block

Perfusion Index Value in Predicting the Clinical Outcome of Axillary Block

The primary endpoint of this study was to identify that Perfusion index (PI) has any predictive value for the treatment outcome of cervical radiculopathy

Study Overview

• Status: Recruiting
• Conditions: Pain, Chronic
• Intervention / Treatment: Procedure: axillary block using 5 ml local anesthetics

Detailed Description

The interscalene brachial plexus block is an effective intervention for reducing postoperative pain but is related to side effects, Suprascapular nerve block and a block of the axillary nerve have been introduced as alternatives to the interscalene brachial plexus for the control of postoperative pain. Previous study demonstrated new method of axillary block using interfascial plane injection guided by ultrasoud. Axillary block has been used widely for the relief of postoperative arm pain.

Recent study deomonstrated good pain relief when ultrasound guided fascial plane injection was performed in patients with cervical radiuculopathy.

The perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter. Although the special probe for PI measurement is relatively more expensive compared with ordinary pulse oximetery probes, its benefit as a marker of peripheral perfusion and as an idex for sympathetic stimulation have increased its use progressively. PI has been used widely for the prediction of success of brachial plexus block or axillary block. Changes of PI ratio value showed an excellent predictive value for the success of block.

There have been no studies demonstrating any predictive value of PI in axillary block for the relief of cervical radiulopathy

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 42601
    • Recruiting
    • Ji Hoon Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who visit the pain clinic

Description

Inclusion Criteria:

• Cervical foraminal stenosis
• Cervical central stenosis
• Cervical disc herniation
• Cervical spondylolisthesis

Exclusion Criteria:

• Infection
• pregnancy
• allergy to local anesthetic agents
• previous cervical spine surgery

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perfusion index changes among 4 time periods	Perfusion index changes among 4 time periods	baseline, 10 minutes, 20 minutes, 30 minutes after axillary block
Number of patients showing numerical rating scale reduction more than 50%	Number of patients showing numerical rating scale reduction more than 50%	1 month after axillary block
Number of patients showing numerical rating scale reduction less than 50%	Number of patients showing numerical rating scale reduction less than 50%	1 month after axillary block
Number of patients showing no reduction in numerical rating scale	Number of patients showing no reduction in numerical rating scale	1 month after axillary block
Neck disability index changes between 2 time periods	Neck disability index changes between 2 time periods	baseline, 1 month after axillary block

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 20201-025-04

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