NCT04941235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

June 20, 2021

Last Update Submit

June 26, 2021

Conditions

Shoulder and Upper Arm Injury

Keywords

shoulder arthroscopy

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 hour

Study Arms (4)

NU group

ACTIVE COMPARATOR

Bth nerve stimulator and ultrasound guided interscalene brachial plexus block

Device: ultrasound and nerve stimulator

U group

ACTIVE COMPARATOR

Ultrasound guided interscalene brachial plexus block

Device: ultrasound and nerve stimulator

N group

ACTIVE COMPARATOR

Nerve stimulator guided interscalene brachial plexus block

Device: ultrasound and nerve stimulator

C group

NO INTERVENTION

No block only IV analgesics

Interventions

ultrasound and nerve stimulatorDEVICE

nerve stimulator and ultrasound guided interscalene brachial plexus block

N groupNU groupU group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18-65 years old.
  • Sex: Both sexes.
  • ASA I \& II.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medcine

Minya, 61111, Egypt

Location

MeSH Terms

Conditions

Arm Injuries

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Ahmed K Mohamed, MD

    Professor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

June 20, 2021

First Posted

June 28, 2021

Study Start

May 1, 2018

Primary Completion

May 1, 2019

Study Completion

August 31, 2020

Last Updated

June 30, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)