Diabetic PatientNCT04903743
POPLITEAL SCIATIC NERVE BLOCK FOR DIABETIC FOOT SURGERIES
A study testing bupivacaine and magnesium sulfate in people with Diabetic Patient, run by Alexandria University at 1 site in Egypt.
Trial summary
Popliteal Sciatic nerve block is a regional technique that provides safe and reliable perioperative anesthesia and analgesia of lower leg and foot used in diabetic patients. Different additives have been used with local anaesthetics to achieve dense and prolonged block. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetic Patient
- What is being tested?
- bupivacaine and magnesium sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2021to 10 Jul 2021
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (ASA) II or III
- scheduled for diabetic foot surgeries.
Who cannot join
- Patients who refused the anaesthetic technique,
- whose BMI ≥ 35 kg/ m2,
- unable to properly describe postoperative pain to investigator (dementia, delirium, psychiatric and neurological disorders),
- patients with coagulopathy, skin infection at the site of injection,
- preoperative use of opioid or non-steroidal anti-inflammatory drugs,
- allergy or contraindication to studied medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ULTRASOUND GUIDED POPLITEAL SCIATIC NERVE BLOCK USING BUPIVACAINE ALONE OR COMBINED WITH MAGNESIUM SULFATE FOR DIABETIC FOOT SURGERIES
Popliteal Sciatic nerve block is a regional technique that provides safe and reliable perioperative anesthesia and analgesia of lower leg and foot used in diabetic patients. Different additives have been used with local anaesthetics to achieve dense and prolonged block. Magnesium sulfate possesses analgesic properties owing to its effect on NMDA receptors.
- Conditions
- Diabetic Patient
- Being tested
- bupivacaine, magnesium sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaineDrug
group B received 28ml of 0.25% bupivacaine and 2ml normal saline
magnesium sulfateDrug
group BM received 28 ml of 0.25% bupivacaine and 2 ml magnesium sulfate 10%.
| Study group | Role | What they receive |
|---|---|---|
| group B | Placebo comparator | 28ml of 0.25% bupivacaine and 2ml normal saline Receives: Drug: bupivacaine |
| group BM | Active comparator | received 28 ml of 0.25% bupivacaine and 2 ml magnesium sulfate 10%. Receives: Drug: bupivacaine; Drug: magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of postoperative analgesia
evaluate the effects of adding magnesium sulfate to bupivacaine versus bupivacaine alone in popliteal sciatic nerve block with ultrasound guidance for diabetic foot surgeries as regards the duration of postoperative analgesia
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 posted26 May 2021
- Study start10 Jan 2021
- Primary completion20 Jun 2021 (estimated)
- Study completion10 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PatientStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rehab zayed, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903743
- Sponsor's protocol ID
- 0106292
- Status last verified
- May 2021
- First submitted
- 24 May 2021
- Last updated
- 27 May 2021
- 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 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ULTRASOUND GUIDED POPLITEAL SCIATIC NERVE BLOCK USING BUPIVACAINE ALONE OR COMBINED WITH MAGNESIUM SULFATE FOR DIABETIC FOOT SURGERIES
- ClinicalTrials.gov ID
- NCT04903743
- Acronym / sponsor ID
- 0106292
- Conditions
- Diabetic Patient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 20 Jun 2021 (estimated)
- Study completion
- 10 Jul 2021 (estimated)
- First posted
- 26 May 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.
Popliteal Sciatic nerve block is a regional technique that provides safe and reliable perioperative anesthesia and analgesia of lower leg and foot used in diabetic patients. Different additives have been used with local anaesthetics to achieve dense and prolonged block. Magnesium sulfate possesses analgesic properties owing to its effect on NMDA receptors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group B | Placebo comparator | Drug: bupivacaine28ml of 0.25% bupivacaine and 2ml normal saline |
| group BM | Active comparator | Drug: bupivacaine, Drug: magnesium sulfatereceived 28 ml of 0.25% bupivacaine and 2 ml magnesium sulfate 10%. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (ASA) II or III
- scheduled for diabetic foot surgeries.
Key exclusion criteria (6 listed)
- Patients who refused the anaesthetic technique,
- whose BMI ≥ 35 kg/ m2,
- unable to properly describe postoperative pain to investigator (dementia, delirium, psychiatric and neurological disorders),
- patients with coagulopathy, skin infection at the site of injection,
- preoperative use of opioid or non-steroidal anti-inflammatory drugs,
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 |
|---|---|---|
| bupivacainegroup B received 28ml of 0.25% bupivacaine and 2ml normal saline | Drug | group B, group BM |
| magnesium sulfategroup BM received 28 ml of 0.25% bupivacaine and 2 ml magnesium sulfate 10%. | Drug | group BM |
Primary outcome
duration of postoperative analgesia
Time frame: 24 hours
evaluate the effects of adding magnesium sulfate to bupivacaine versus bupivacaine alone in popliteal sciatic nerve block with ultrasound guidance for diabetic foot surgeries as regards the duration of postoperative analgesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
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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 study testing bupivacaine and magnesium sulfate in people with Diabetic Patient, run by Alexandria University at 1 site in Egypt.
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 2 inclusion and 6 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 27 May 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
duration of postoperative analgesia (time frame: 24 hours). 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 27 May 2021.