Postoperative PainPhase 4NCT04833296
Ropivacaine Use in Interscalene Block; What is the Minimal Effective Analgesic Concentration (MEAC 90)
A Phase 4 study testing Ropivacaine in people with Postoperative Pain, run by Healthpoint Hospital at 1 site in United Arab Emirates.
Trial summary
This study aim to calculate the minimal effective ropivacaine concentration required achieve successful analgesic interscalene block in 90% of patients (MEAC90) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ropivacaine
- How many people
- 45 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 May 2021to 30 Sep 2021
- Phase
- Phase 4
- 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 are scheduled for shoulder arthroscopy
Who cannot join
- - <18 y,
- ASA physical class greater >III
- BMI >40 has any contraindication for medications or techniques used in the study
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Healthpoint Hospital
Abu Dhabi, 112308
About this study
This study aim to calculate the minimal effective ropivacaine concentration required achieve successful analgesic interscalene block in 90% of patients (MEAC90)
Read the detailed description
- Before induction of general anesthesia, all patients will receive interscalene block using 15ml of ropivacaine which concentration will be based on the response of the previous patient.
- Based on biased-coin design up-down sequential method: if patient has pain free recovery, a successful block, the next patient will be randomized to receive either the same ropivacaine concentration or a concentration 0.01% w/v less. However, if he has an unsuccessful block, the next patient will receive a concentration 0.01% w/v higher.
- Patients with pain free recovery will be considered to have positive response.
- Patients' responses will be analyzed to calculate the MEAC90.
- Conditions
- Postoperative Pain
- Being tested
- Ropivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
all patients will receive interscalene block using same volume of ropivacaine but in different concentrations
What is being measured
The primary outcome is the main question the study is designed to answer.
effective analgesic interscalene block
postoperative pain (will be assessed using numerical rating scale. if ≥ 3, ineffective block will be considered and if <3, an effective block will be considered
Measured: in recovery unit (one hour after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 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
- NCT04833296
- Sponsor's protocol ID
- MF2467-2021-15
- Status last verified
- Apr 2021
- First submitted
- 31 Mar 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- 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 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ropivacaine Use in Interscalene Block; What is the Minimal Effective Analgesic Concentration (MEAC 90)
- ClinicalTrials.gov ID
- NCT04833296
- Acronym / sponsor ID
- MF2467-2021-15
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Healthpoint HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 6 Apr 2021 (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.
This study aim to calculate the minimal effective ropivacaine concentration required achieve successful analgesic interscalene block in 90% of patients (MEAC90)
Detailed description
- Before induction of general anesthesia, all patients will receive interscalene block using 15ml of ropivacaine which concentration will be based on the response of the previous patient.
- Based on biased-coin design up-down sequential method: if patient has pain free recovery, a successful block, the next patient will be randomized to receive either the same ropivacaine concentration or a concentration 0.01% w/v less. However, if he has an unsuccessful block, the next patient will receive a concentration 0.01% w/v higher.
- Patients with pain free recovery will be considered to have positive response.
- Patients' responses will be analyzed to calculate the MEAC90.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
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 are scheduled for shoulder arthroscopy
Key exclusion criteria (3 listed)
- - <18 y,
- ASA physical class greater >III
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 |
|---|---|---|
| Ropivacaineall patients will receive interscalene block using same volume of ropivacaine but in different concentrations | Drug | – |
Primary outcome
effective analgesic interscalene block
Time frame: in recovery unit (one hour after surgery)
postoperative pain (will be assessed using numerical rating scale. if ≥ 3, ineffective block will be considered and if <3, an effective block will be considered
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine in people with Postoperative Pain, 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 3 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 Apr 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
effective analgesic interscalene block (time frame: in recovery unit (one hour after surgery)). 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 6 Apr 2021.