NCT04317235

Brief Summary

Ropivacaine for ultrasound-guided interscalene block: 3mL provide similar analgesia to 5mL with less diaphragmatic paralysis in shoulder arthroscopy surgeries

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

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

January 10, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2019

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

2.1 years

First QC Date

January 23, 2019

Last Update Submit

March 20, 2020

Conditions

Diaphragmatic Paralysis

Outcome Measures

Primary Outcomes (2)

  • Diaphragmatic paralysis

    on x ray we look if there is an elevated diaphragm

    Up to 48 hours

  • Pain relief

    pain scale 1-10 score 1 no pain and 10 severe pain first by visiting patient before discharge twice and thereafter on the phone

    up to day 2 after operation

Study Arms (2)

3 ml ropivacaine

ACTIVE COMPARATOR

interscalene block using 3 ml under ultrasound put medication on each nerve

Drug: Ropivacaine 0.5% Injectable Solution

5 ml ropivacaine

ACTIVE COMPARATOR

interscalene block using 5 ml under ultrasound put medication on each nerve

Drug: Ropivacaine 0.5% Injectable Solution

Interventions

Ropivacaine 0.5% Injectable SolutionDRUG

Is to put 3 ml or 5 ml and show the difference

Also known as: interscalene
3 ml ropivacaine5 ml ropivacaine

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ASA1-2

You may not qualify if:

  • ASA3-4 anticoagulant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Paralysis

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • hazem kafrouni

    Saint George Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 23, 2019

First Posted

March 23, 2020

Study Start

January 10, 2016

Primary Completion

March 2, 2018

Study Completion

January 20, 2019

Last Updated

March 23, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share