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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

About this trial

This is an interventional prevention trial for Shoulder and Upper Arm Injury focused on measuring shoulder arthroscopy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

NCT ID

NCT04941235

First Posted

June 20, 2021

Last Updated

June 26, 2021

Sponsor

Minia University

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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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