Shoulder Arthropathy Associated With Other ConditionsNCT03331237
Sparing Diaphragm; ISO Block Versus Low Volume Scalene Block
A study testing scalene block and ISO block in people with Shoulder Arthropathy Associated With Other Conditions, run by Healthpoint Hospital at 1 site in United Arab Emirates.
Trial summary
For shoulder analgesia, both ISO block and low volume scalene (LVS) block (using 5 ml of local anesthetics) are suggested to have a low incidence of hemi-diaphragmatic pariesis (HDP). The aim of this study was to compare the incidence of HDP and the analgesic efficacy of the LVS block versus ISO block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Arthropathy Associated With Other Conditions
- What is being tested?
- scalene block and ISO block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 9 Oct 2017to Apr 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who were scheduled for arthroscopic shoulder surgery
Who cannot join
- aged <18y
- BMI >35,
- ASA greater >III,
- an infection at the injection site
- has a contraindication for laryngeal mask or the medications used in this study.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Healthpoint Hospital
Abu Dhabi, 112308
Sabah Zahooruddin, +971 2 4921304, s.zahooruddin@healthpoint.ae
About this study
Official title: Shoulder Analgesia Sparing Diaphragm; ISO Block Versus Low Volume Scalene Block. A Randomized Controlled Double Blind Study
For shoulder analgesia, both ISO block and low volume scalene (LVS) block (using 5 ml of local anesthetics) are suggested to have a low incidence of hemi-diaphragmatic pariesis (HDP).
The aim of this study was to compare the incidence of HDP and the analgesic efficacy of the LVS block versus ISO block.
- Being tested
- scalene block, ISO block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scalene blockProcedure or surgery
scalene block using 5ml of ropivacaine
ISO blockProcedure or surgery
ISO block is a combined block of suprascapular nerve and brachial plexus cords using a single puncture
| Study group | Role | What they receive |
|---|---|---|
| LVS group | Active comparator | interscalene injection Receives: Procedure: scalene block |
| ISO group | Active comparator | in this group all patients will receive ISO block. Receives: Procedure: ISO block |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemi-diaphragmatic pariesis
diaphragmatic caudal displacement will be measured (in cm) with real time ultrasound before the block performance and after the procedure
Measured: 2-4 hours
Secondary outcomes (4)
analgesic efficacy (block success)
successful block = pain free (VAS 0) in recovery unit. VAS will be used to evaluate the pain (0 = pain free, 10= most sever pain)
Measured: 2-4 hours
patient satisfaction
if the patient is satisfied with the analgesia technique or not
Measured: 24 hours
duration of analgesia
duration between the block performance and the first requesting of pain killer (morphine)
Measured: 24 hours
total morphine dose
the total morphine consumption within 24 hrs after the block performance
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start9 Oct 2017
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder Arthropathy Associated With Other ConditionsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healthpoint Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Muhammad Taha, Healthpoint Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331237
- Sponsor's protocol ID
- REC007
- Status last verified
- Oct 2017
- First submitted
- 28 Oct 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taha AM, Yurdi NA, Elahl MI, Abd-Elmaksoud AM. Diaphragm-sparing effect of the infraclavicular subomohyoid block vs low volume interscalene block. A randomized blinded study. Acta Anaesthesiol Scand. 2019 May;63(5):653-658. doi: 10.1111/aas.13322. Epub 2019 Jan 30.
PubMed 30697688
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shoulder Analgesia Sparing Diaphragm; ISO Block Versus Low Volume Scalene Block. A Randomized Controlled Double Blind Study
- ClinicalTrials.gov ID
- NCT03331237
- Acronym / sponsor ID
- REC007
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Healthpoint HospitalUniversity, hospital or other
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 6 Nov 2017 (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.
For shoulder analgesia, both ISO block and low volume scalene (LVS) block (using 5 ml of local anesthetics) are suggested to have a low incidence of hemi-diaphragmatic pariesis (HDP).
The aim of this study was to compare the incidence of HDP and the analgesic efficacy of the LVS block versus ISO block.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LVS group | Active comparator | Procedure: scalene blockinterscalene injection |
| ISO group | Active comparator | Procedure: ISO blockin this group all patients will receive ISO block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who were scheduled for arthroscopic shoulder surgery
Key exclusion criteria (5 listed)
- aged <18y
- BMI >35,
- ASA greater >III,
- an infection at the injection site
- has a contraindication for laryngeal mask or the medications used in this study.
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 |
|---|---|---|
| scalene blockscalene block using 5ml of ropivacaine | Procedure or surgery | LVS group |
| ISO blockISO block is a combined block of suprascapular nerve and brachial plexus cords using a single puncture | Procedure or surgery | ISO group |
Primary outcome
hemi-diaphragmatic pariesis
Time frame: 2-4 hours
diaphragmatic caudal displacement will be measured (in cm) with real time ultrasound before the block performance and after the procedure
4 secondary outcomes
analgesic efficacy (block success)
Time frame: 2-4 hours
patient satisfaction
Time frame: 24 hours
duration of analgesia
Time frame: 24 hours
total morphine dose
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 30697688Taha AM, Yurdi NA, Elahl MI, Abd-Elmaksoud AM. Diaphragm-sparing effect of the infraclavicular subomohyoid block vs low volume interscalene block. A randomized blinded study. Acta Anaesthesiol Scand. 2019 May;63(5):653-658. doi: 10.1111/aas.13322. Epub 2019 Jan 30.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scalene block and ISO block in people with Shoulder Arthropathy Associated With Other Conditions, run by Healthpoint Hospital at 1 site in United Arab Emirates.
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 5 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: status not confirmed, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabah Zahooruddin (009712 4929000 ext. 1304, s.zahooruddin@helathpoint.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemi-diaphragmatic pariesis (time frame: 2-4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03331237, which also lists 1 linked publication.
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 6 Nov 2017.