End Stage Renal FailureNCT06389617
Different Doses of Intravenous Administered Dexamethasone Effecting Brachial Plexus Supraclavicular Block
A study testing supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasone in people with End Stage Renal Failure, run by Hospital Universiti Sains Malaysia.
Trial summary
To compare the analgesic properties of ultrasound guided supraclavicular block using ropivacaine 0.5% in arteriovenous fistula creation when used in combination with intravenous administered dexamethasone at 4mg and 8 mg as an adjuvant Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- End Stage Renal Failure
- What is being tested?
- supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 30 Dec 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, age 18 to 65 years End stage renal disease patients for AV fistula creation
Who cannot join
- Not suitable candidate as determined by the primary team Refusal for brachial plexus block History of allergy to dexamethasone or local anesthesia Pregnancy History of previous brachial plexus injury Coagulopathy Local skin site infection Known neuropathy involving the arm undergoing surgery Patients with glucose reading more then 12mmol/
About this study
Official title: Different Doses of Intravenous Administered Dexamethasone Effecting Brachial Plexus Supraclavicular Block for Creation of Arteriovenous Fistula in End Stage Renal Disease: A Randomized Controlled Trial
To compare the analgesic properties of ultrasound guided supraclavicular block using ropivacaine 0.5% in arteriovenous fistula creation when used in combination with intravenous administered dexamethasone at 4mg and 8 mg as an adjuvant
- Conditions
- End Stage Renal Failure
- Being tested
- supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasone
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasoneDrug
Comparing the onset of sensory, motor block, duration of motor block and analgesic duration
| Study group | Role | What they receive |
|---|---|---|
| GROUP DF | Active comparator | supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous dexamethasone 4mg Receives: Drug: supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasone |
| GROUP DE | Active comparator | supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous dexamethasone 8mg Receives: Drug: supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the difference of onset time between sensory and motor block of supraclavicular block between ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg
Measured: 2 days
To compare the difference in duration of analgesia between supraclavicular block with ropivacaine and IV dexamethasone 4mg with ropivacaine and IV dexamethasone 8mg
Measured: 2 days
Secondary outcomes (1)
To compare the duration difference of the return of motor block between supraclavicular block using ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal FailureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prem Anand A/L Tb Nantha Kumar, Hospital Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389617
- Sponsor's protocol ID
- USM/JEPeM/KK/24010061
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Doses of Intravenous Administered Dexamethasone Effecting Brachial Plexus Supraclavicular Block for Creation of Arteriovenous Fistula in End Stage Renal Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06389617
- Acronym / sponsor ID
- USM/JEPeM/KK/24010061
- Conditions
- End Stage Renal Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 29 Apr 2024 (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.
To compare the analgesic properties of ultrasound guided supraclavicular block using ropivacaine 0.5% in arteriovenous fistula creation when used in combination with intravenous administered dexamethasone at 4mg and 8 mg as an adjuvant
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP DF | Active comparator | Drug: supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasonesupraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous dexamethasone 4mg |
| GROUP DE | Active comparator | Drug: supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasonesupraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous dexamethasone 8mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult, age 18 to 65 years End stage renal disease patients for AV fistula creation
Key exclusion criteria (1 listed)
- Not suitable candidate as determined by the primary team Refusal for brachial plexus block History of allergy to dexamethasone or local anesthesia Pregnancy History of previous brachial plexus injury Coagulopathy Local skin site infection Known neuropathy involving the arm undergoing surgery Patients with glucose reading more then 12mmol/
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 |
|---|---|---|
| supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasoneComparing the onset of sensory, motor block, duration of motor block and analgesic duration | Drug | GROUP DE, GROUP DF |
Primary outcome
To compare the difference of onset time between sensory and motor block of supraclavicular block between ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg
Time frame: 2 days
To compare the difference in duration of analgesia between supraclavicular block with ropivacaine and IV dexamethasone 4mg with ropivacaine and IV dexamethasone 8mg
Time frame: 2 days
1 secondary outcome
To compare the duration difference of the return of motor block between supraclavicular block using ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasone in people with End Stage Renal Failure, run by Hospital Universiti Sains Malaysia.
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: status not confirmed, as of the sponsor's last update on 29 Apr 2024. 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?
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?
To compare the difference of onset time between sensory and motor block of supraclavicular block between ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg (time frame: 2 days). 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 29 Apr 2024.