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

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

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

Study Overview

• Status: Completed
• Conditions: Diaphragmatic Paralysis
• Intervention / Treatment: Drug: Ropivacaine 0.5% Injectable Solution

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA1-2

Exclusion Criteria:

• ASA3-4 anticoagulant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Saint George Hospital
• Investigators: Principal Investigator: hazem kafrouni, Saint George Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2016
• Primary Completion (Actual): March 2, 2018
• Study Completion (Actual): January 20, 2019

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (Actual): March 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 20, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Respiratory Insufficiency; Paralysis; Respiratory Paralysis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: SaintgeorgeH

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