The Effectiveness of Different Techniques of Interscalene Brachial Plexus Block With General Anesthesia for Shoulder Arthroscopy
Primary Purpose
Shoulder and Upper Arm Injury
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound and nerve stimulator
Sponsored by
About this trial
This is an interventional prevention trial for Shoulder and Upper Arm Injury focused on measuring shoulder arthroscopy
Eligibility Criteria
Inclusion Criteria:
- Age: 18-65 years old.
- Sex: Both sexes.
- ASA I & II.
Exclusion Criteria:
- - Patient refusal.
- Bleeding disorders.
- Damage or disease of the brachial plexus.
- ASA more than II.
- Pre-existing peripheral neuropathy.
- Patients with neuromuscular diseases.
- Patients with known hypersensitivity to drugs of the study.
- Patients with local skin infection at the site of injection.
- Psychiatric diseases interfering with evaluation of the block.
Sites / Locations
- Faculty of Medcine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
No Intervention
Arm Label
NU group
U group
N group
C group
Arm Description
Bth nerve stimulator and ultrasound guided interscalene brachial plexus block
Ultrasound guided interscalene brachial plexus block
Nerve stimulator guided interscalene brachial plexus block
No block only IV analgesics
Outcomes
Primary Outcome Measures
Analgesic effect of each technique
using visual analogue scale for pain The patient is asked to express the degree of pain in numbers from 0-10, where 0 means no pain and 10 represents severe pain.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04941235
Brief Title
The Effectiveness of Different Techniques of Interscalene Brachial Plexus Block With General Anesthesia for Shoulder Arthroscopy
Official Title
The Effectiveness of Different Techniques of Interscalene Brachial Plexus Block With General Anesthesia for Shoulder Arthroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
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
There are different techniques of interscalene brachial plexus block, we aimed to evaluate the effectiveness of 3 of them as analgesia during shoulder arthroscopy surgery under general anesthesia.
Detailed Description
Prospective randomized controlled study
There were 4 groups included in our study:
Group N: nerve stimulator guided interscalene brachial plexus block was done Group U: ultrasound guided interscalene brachial plexus block was done Group NU: dual guidance (using both nerve stimulator and ultrasound) Group C: control group We assessed in each group: heart rate, noninvasive blood pressure, time needed for block, onset of sensory and motor power loss and their offset, and finally patient satisfaction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder and Upper Arm Injury
Keywords
shoulder arthroscopy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NU group
Arm Type
Active Comparator
Arm Description
Bth nerve stimulator and ultrasound guided interscalene brachial plexus block
Arm Title
U group
Arm Type
Active Comparator
Arm Description
Ultrasound guided interscalene brachial plexus block
Arm Title
N group
Arm Type
Active Comparator
Arm Description
Nerve stimulator guided interscalene brachial plexus block
Arm Title
C group
Arm Type
No Intervention
Arm Description
No block only IV analgesics
Intervention Type
Device
Intervention Name(s)
ultrasound and nerve stimulator
Intervention Description
nerve stimulator and ultrasound guided interscalene brachial plexus block
Primary Outcome Measure Information:
Title
Analgesic effect of each technique
Description
using visual analogue scale for pain The patient is asked to express the degree of pain in numbers from 0-10, where 0 means no pain and 10 represents severe pain.
Time Frame
12 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: 18-65 years old.
Sex: Both sexes.
ASA I & II.
Exclusion Criteria:
- Patient refusal.
Bleeding disorders.
Damage or disease of the brachial plexus.
ASA more than II.
Pre-existing peripheral neuropathy.
Patients with neuromuscular diseases.
Patients with known hypersensitivity to drugs of the study.
Patients with local skin infection at the site of injection.
Psychiatric diseases interfering with evaluation of the block.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed K Mohamed, MD
Organizational Affiliation
Professor
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medcine
City
Minya
ZIP/Postal Code
61111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effectiveness of Different Techniques of Interscalene Brachial Plexus Block With General Anesthesia for Shoulder Arthroscopy
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