Ultrasound-guided Interscalene Block:3mL Ropi Provide Similar Analgesia to 5mL and Less Diaphragmatic Paralysis

Sponsor

Saint George Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04317235

Collaborator

(none)

Enrollment

Arms

36.3

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diaphragmatic Paralysis	Drug: Ropivacaine 0.5% Injectable Solution	N/A

Detailed Description

Ropivacaine for ultrasound-guided interscalene block: 3mL provide similar analgesia to 5mL with less diaphragmatic paralysis in shoulder arthroscopy surgeries with no toxicity and no adverse reaction or complications we targeted under echography each nerve to be blocked alone either to put around all the nerves a big volume

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Ropivacaine for Ultrasound-guided Interscalene Block: 3mL Provide Similar Analgesia to 5mL With Less Diaphragmatic Paralysis in Shoulder Arthroscopy Surgeries

Actual Study Start Date :

Jan 10, 2016

Actual Primary Completion Date :

Mar 2, 2018

Actual Study Completion Date :

Jan 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 3 ml ropivacaine interscalene block using 3 ml under ultrasound put medication on each nerve	Drug: Ropivacaine 0.5% Injectable Solution Is to put 3 ml or 5 ml and show the difference Other Names: interscalene
Active Comparator: 5 ml ropivacaine interscalene block using 5 ml under ultrasound put medication on each nerve	Drug: Ropivacaine 0.5% Injectable Solution Is to put 3 ml or 5 ml and show the difference Other Names: interscalene

Arm

Intervention/Treatment

Active Comparator: 3 ml ropivacaine

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

Drug: Ropivacaine 0.5% Injectable Solution

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

Other Names:

interscalene

Active Comparator: 5 ml ropivacaine

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

Drug: Ropivacaine 0.5% Injectable Solution

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

Other Names:

interscalene

Outcome Measures

Primary Outcome Measures

Diaphragmatic paralysis [Up to 48 hours]
on x ray we look if there is an elevated diaphragm
Pain relief [up to day 2 after operation]
pain scale 1-10 score 1 no pain and 10 severe pain first by visiting patient before discharge twice and thereafter on the phone

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

ASA1-2

Exclusion Criteria:

ASA3-4 anticoagulant

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Saint George Hospital

Investigators

Principal Investigator: hazem kafrouni, Saint George Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hazem Kafrouni, Assistant professor, Saint George Hospital

ClinicalTrials.gov Identifier:

NCT04317235

Other Study ID Numbers:

SaintgeorgeH

First Posted:

Mar 23, 2020

Last Update Posted:

Mar 23, 2020

Last Verified:

Mar 1, 2020

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:

Additional relevant MeSH terms:

Respiratory Paralysis

Paralysis

Ropivacaine

Study Results

No Results Posted as of Mar 23, 2020