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Clinical Efficacy of Axillary Block in Cervical Radiculopathy

Primary Purpose

Pain, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
axillary block guided by ultrasound
Sponsored by
Keimyung University Dongsan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Cervical foraminal stenosis Cervical central stenosis Cervical disc herniation Cervical spondylolisthesis Prominent arm pain rather than neck pain Exclusion Criteria: Infection Pregnancy allergy to local anesthetic agents previous cervical spine surgery Prominent neck pain rather than arm pain

Sites / Locations

  • Hong ji HEERecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

5ml axillary block group

10ml axillary block group

Arm Description

interfascial plane axillary block group using 5 ml local anesthetics

interfascial plane axillary block group using 10 ml local anesthetics

Outcomes

Primary Outcome Measures

Numerical rating scale changes among 4 time periods
Numerical rating scale changes among 4 time periods
Neck disability injex changes between 2 time periods
Neck disability injex changes between 2 time periods

Secondary Outcome Measures

Full Information

First Posted
February 3, 2023
Last Updated
February 13, 2023
Sponsor
Keimyung University Dongsan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05723354
Brief Title
Clinical Efficacy of Axillary Block in Cervical Radiculopathy
Official Title
Comparison of Clinical Efficacy of Axillary Block in Patients of Cervical Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keimyung University Dongsan Medical Center

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 primary endpoint of this study was to compare the clinical efficacy of axillary block in patients of cervical radiculopathy using 2 volumes of 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 interfascial plane injection was performed in patients with cervical radiuculopathy. There is no study showing clinical efficacy of interfascial plane injection of axillary block in patients of cervical radiculopathy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
5ml axillary block group
Arm Type
Active Comparator
Arm Description
interfascial plane axillary block group using 5 ml local anesthetics
Arm Title
10ml axillary block group
Arm Type
Active Comparator
Arm Description
interfascial plane axillary block group using 10 ml local anesthetics
Intervention Type
Procedure
Intervention Name(s)
axillary block guided by ultrasound
Intervention Description
axillary block using local anesthetics
Primary Outcome Measure Information:
Title
Numerical rating scale changes among 4 time periods
Description
Numerical rating scale changes among 4 time periods
Time Frame
baseline, 2 weeks after injection, 4 weeks after injection, 8 weeks after injection
Title
Neck disability injex changes between 2 time periods
Description
Neck disability injex changes between 2 time periods
Time Frame
baseline, 8 weeks after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cervical foraminal stenosis Cervical central stenosis Cervical disc herniation Cervical spondylolisthesis Prominent arm pain rather than neck pain Exclusion Criteria: Infection Pregnancy allergy to local anesthetic agents previous cervical spine surgery Prominent neck pain rather than arm pain
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji H Hong
Phone
01046794343
Email
swon13@daum.net
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Hoon Park
Phone
+82532587760
Email
cmjihoon@gmail.com
Facility Information:
Facility Name
Hong ji HEE
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J Hee Hong
Phone
82-53-258-7767
Email
swon13@daum.net

12. IPD Sharing Statement

Learn more about this trial

Clinical Efficacy of Axillary Block in Cervical Radiculopathy

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