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

June 26, 2021 updated by: Shery Shehata Kyriacos, Minia University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 61111
        • Faculty of Medcine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic effect of each technique
Time Frame: 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.
12 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Study Chair: Ahmed K Mohamed, MD, Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

August 31, 2020

Study Registration Dates

First Submitted

June 20, 2021

First Submitted That Met QC Criteria

June 20, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Actual)

June 30, 2021

Last Update Submitted That Met QC Criteria

June 26, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 219:7/2019

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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