Back to resultsUltrasound-guided Interscalene Block:3mL Ropi Provide Similar Analgesia to 5mL and Less Diaphragmatic Paralysis
Primary Purpose
Diaphragmatic Paralysis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ropivacaine 0.5% Injectable Solution
Sponsored by
About this trial
This is an interventional prevention trial for Diaphragmatic Paralysis
Eligibility Criteria
Inclusion Criteria:
- ASA1-2
Exclusion Criteria:
- ASA3-4 anticoagulant
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
3 ml ropivacaine
5 ml ropivacaine
Arm Description
interscalene block using 3 ml under ultrasound put medication on each nerve
interscalene block using 5 ml under ultrasound put medication on each nerve
Outcomes
Primary Outcome Measures
Diaphragmatic paralysis
on x ray we look if there is an elevated diaphragm
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04317235
Brief Title
Ultrasound-guided Interscalene Block:3mL Ropi Provide Similar Analgesia to 5mL and Less Diaphragmatic Paralysis
Official Title
Ropivacaine for Ultrasound-guided Interscalene Block: 3mL Provide Similar Analgesia to 5mL With Less Diaphragmatic Paralysis in Shoulder Arthroscopy Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2016 (Actual)
Primary Completion Date
March 2, 2018 (Actual)
Study Completion Date
January 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint George Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Ropivacaine for ultrasound-guided interscalene block: 3mL provide similar analgesia to 5mL with less diaphragmatic paralysis in shoulder arthroscopy surgeries
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diaphragmatic Paralysis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3 ml ropivacaine
Arm Type
Active Comparator
Arm Description
interscalene block using 3 ml under ultrasound put medication on each nerve
Arm Title
5 ml ropivacaine
Arm Type
Active Comparator
Arm Description
interscalene block using 5 ml under ultrasound put medication on each nerve
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5% Injectable Solution
Other Intervention Name(s)
interscalene
Intervention Description
Is to put 3 ml or 5 ml and show the difference
Primary Outcome Measure Information:
Title
Diaphragmatic paralysis
Description
on x ray we look if there is an elevated diaphragm
Time Frame
Up to 48 hours
Title
Pain relief
Description
pain scale 1-10 score 1 no pain and 10 severe pain first by visiting patient before discharge twice and thereafter on the phone
Time Frame
up to day 2 after operation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ASA1-2
Exclusion Criteria:
ASA3-4 anticoagulant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hazem kafrouni
Organizational Affiliation
Saint George Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ultrasound-guided Interscalene Block:3mL Ropi Provide Similar Analgesia to 5mL and Less Diaphragmatic Paralysis
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