Diaphragmatic ParalysisNCT04317235
Ultrasound-guided Interscalene Block:3mL Ropi Provide Similar Analgesia to 5mL and Less Diaphragmatic Paralysis
A study testing Ropivacaine 0.5% Injectable Solution in people with Diaphragmatic Paralysis, run by Saint George Hospital.
Trial summary
Ropivacaine for ultrasound-guided interscalene block: 3mL provide similar analgesia to 5mL with less diaphragmatic paralysis in shoulder arthroscopy surgeries Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diaphragmatic Paralysis
- What is being tested?
- Ropivacaine 0.5% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2016to 20 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ASA1-2
Who cannot join
- ASA3-4 anticoagulant
About this study
Official title: 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
Read the 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
- Conditions
- Diaphragmatic Paralysis
- Being tested
- Ropivacaine 0.5% Injectable Solution
- Medical subject headings
- Respiratory Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.5% Injectable SolutionDrug
Also called interscalene
Is to put 3 ml or 5 ml and show the difference
| Study group | Role | What they receive |
|---|---|---|
| 3 ml ropivacaine | Active comparator | interscalene block using 3 ml under ultrasound put medication on each nerve Receives: Drug: Ropivacaine 0.5% Injectable Solution |
| 5 ml ropivacaine | Active comparator | interscalene block using 5 ml under ultrasound put medication on each nerve Receives: Drug: Ropivacaine 0.5% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic paralysis
on x ray we look if there is an elevated diaphragm
Measured: 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
Measured: up to day 2 after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start10 Jan 2016
- Primary completion2 Mar 2018
- Study completion20 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragmatic ParalysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint George Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazem Kafrouni, Saint George Hospital
- Investigators
- hazem kafrouni, Principal investigator, Saint George Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317235
- Sponsor's protocol ID
- SaintgeorgeH
- Status last verified
- Mar 2020
- First submitted
- 23 Jan 2019
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ropivacaine for Ultrasound-guided Interscalene Block: 3mL Provide Similar Analgesia to 5mL With Less Diaphragmatic Paralysis in Shoulder Arthroscopy Surgeries
- ClinicalTrials.gov ID
- NCT04317235
- Acronym / sponsor ID
- SaintgeorgeH
- Conditions
- Diaphragmatic Paralysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Saint George HospitalUniversity, hospital or other
- Study start
- 10 Jan 2016 (actual)
- Primary completion
- 2 Mar 2018 (actual)
- Study completion
- 20 Jan 2019 (actual)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 ml ropivacaine | Active comparator | Drug: Ropivacaine 0.5% Injectable Solutioninterscalene block using 3 ml under ultrasound put medication on each nerve |
| 5 ml ropivacaine | Active comparator | Drug: Ropivacaine 0.5% Injectable Solutioninterscalene block using 5 ml under ultrasound put medication on each nerve |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ASA1-2
Key exclusion criteria (1 listed)
- ASA3-4 anticoagulant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine 0.5% Injectable SolutionAlso: interscaleneIs to put 3 ml or 5 ml and show the difference | Drug | 3 ml ropivacaine, 5 ml ropivacaine |
Primary outcome
Diaphragmatic paralysis
Time frame: Up to 48 hours
on x ray we look if there is an elevated diaphragm
Pain relief
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hazem kafrouni principal investigator
Saint George Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine 0.5% Injectable Solution in people with Diaphragmatic Paralysis, run by Saint George Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic paralysis (time frame: Up to 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.