The Effectiveness of Different Techniques of Interscalene Brachial Plexus Block With General Anesthesia for Shoulder Arthroscopy

Sponsor

Minia University (Other)

Overall Status

Completed

CT.gov ID

NCT04941235

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder and Upper Arm Injury	Device: ultrasound and nerve stimulator	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

The Effectiveness of Different Techniques of Interscalene Brachial Plexus Block With General Anesthesia for Shoulder Arthroscopy

Actual Study Start Date :

May 1, 2018

Actual Primary Completion Date :

May 1, 2019

Actual Study Completion Date :

Aug 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: NU group Bth nerve stimulator and ultrasound guided interscalene brachial plexus block	Device: ultrasound and nerve stimulator nerve stimulator and ultrasound guided interscalene brachial plexus block
Active Comparator: U group Ultrasound guided interscalene brachial plexus block	Device: ultrasound and nerve stimulator nerve stimulator and ultrasound guided interscalene brachial plexus block
Active Comparator: N group Nerve stimulator guided interscalene brachial plexus block	Device: ultrasound and nerve stimulator nerve stimulator and ultrasound guided interscalene brachial plexus block
No Intervention: C group No block only IV analgesics

Outcome Measures

Primary Outcome Measures

Analgesic effect of each technique [12 hour]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medcine	Minya		Egypt	61111

Sponsors and Collaborators

Minia University

Investigators

Study Chair: Ahmed K Mohamed, MD, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shery Shehata Kyriacos, Assistant Lecturer, Minia University

ClinicalTrials.gov Identifier:

NCT04941235

Other Study ID Numbers:

219:7/2019

First Posted:

Jun 28, 2021

Last Update Posted:

Jun 30, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shery Shehata Kyriacos, Assistant Lecturer, Minia University

shoulder arthroscopy

Additional relevant MeSH terms:

Arm Injuries

Study Results

No Results Posted as of Jun 30, 2021