Hip FracturesPhase 2/3Peng BlockNCT06180031
Effect of Adding Magnesium Sulphate in Pericapsular Nerve Group Block
A Phase 2/3 study testing Pericapsular nerve group block using bupivicaine and magnesium sulphate in people with Hip Fractures, run by Assiut University at 1 site in Egypt.
Trial summary
Our aim will be to compare the analgesic efficacy and safety of magnesium sulphate as an adjuvant to bupivacaine in pericapsular nerve group block in Hip joint surgeries. Our primary outcome of the study: total amount of postoperative morphine consumption in the first 24h postoperative. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Pericapsular nerve group block using bupivicaine and magnesium sulphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 30 Mar 2025
- Phase
- Phase 2/3
- 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
- • Patients aged 18 years or more.
- Patients with American society of anesthesiologists (ASA) classification class I or II
- Patients weight range from 50 to 90 Kgs
Who cannot join
- • Patient refusal of peripheral nerve block
- Patient with infection at the site of injection
- Patient with coagulopathy
- Patients with known allergy to used medications.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut University Hospital
Asyut, 71515
Mustafa M Bekhet, MBBCH, +201060286688, mustafabekhet708@gmail.com
Mustafa M Bekhet, MBBCH
About this study
Official title: Effect of Adding Magnesium Sulphate to Bupivacaine in Ultrasound Guided Pericapsular Nerve Group Block for Post Operative Analgesia in Hip Joints Surgeries
Our aim will be to compare the analgesic efficacy and safety of magnesium sulphate as an adjuvant to bupivacaine in pericapsular nerve group block in Hip joint surgeries.
- Our primary outcome of the study: total amount of postoperative morphine consumption in the first 24h postoperative.
- Our secondary outcome of the study: mean arterial blood pressure, heart rate, respiratory rate, adverse effects, block related complication, sedation score (by Ramsay sedation scale) and pain score (by Visual Analog Scale)
- Conditions
- Hip Fractures
- Being tested
- Pericapsular nerve group block using bupivicaine and magnesium sulphate
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular nerve group block using bupivicaine and magnesium sulphateDrug
This technique involves the deposition of the local anesthetic in the fascial plane between the psoas muscle and the superior pubic ramus
| Study group | Role | What they receive |
|---|---|---|
| Group C (control) | No intervention | will have Peng block using 20mg bupivacaine 0.25% |
| Group M | Active comparator | will have PENG block with 2mg magnesium sulphate 10% as an adjuvant to 20mg of bupivacaine 0.25% Receives: Drug: Pericapsular nerve group block using bupivicaine and magnesium sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain management
total amount of postoperative morphine consumption in the first 24 hours postoperatively.
Measured: 24 hours postoperatively
Secondary outcomes (1)
Visual analog scale
It's a scale from 0 to 10 where 0 means no pain and 10 means worst pain imaginable
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Mahmoud Muhammed Bekhet, Assiut University
- Investigators
- Alaa M Attia, Professor, Study chair, Assiut UniversityFatma A Abd Diab, Associate Professor, Study director, South Egypt's cancer institute, Assiut UniversityMoaz Tohamy, Lecturer, Study director, South Egypt's cancer institute, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180031
- Sponsor's protocol ID
- 04-2023-200535
- Acronym
- Peng Block
- Status last verified
- Dec 2023
- First submitted
- 2 Dec 2023
- Last updated
- 22 Dec 2023
- 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 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Magnesium Sulphate to Bupivacaine in Ultrasound Guided Pericapsular Nerve Group Block for Post Operative Analgesia in Hip Joints Surgeries
- ClinicalTrials.gov ID
- NCT06180031
- Acronym / sponsor ID
- Peng Block / 04-2023-200535
- Conditions
- Hip Fractures
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 22 Dec 2023 (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.
Our aim will be to compare the analgesic efficacy and safety of magnesium sulphate as an adjuvant to bupivacaine in pericapsular nerve group block in Hip joint surgeries.
- Our primary outcome of the study: total amount of postoperative morphine consumption in the first 24h postoperative.
- Our secondary outcome of the study: mean arterial blood pressure, heart rate, respiratory rate, adverse effects, block related complication, sedation score (by Ramsay sedation scale) and pain score (by Visual Analog Scale)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C (control) | No intervention | –will have Peng block using 20mg bupivacaine 0.25% |
| Group M | Active comparator | Drug: Pericapsular nerve group block using bupivicaine and magnesium sulphatewill have PENG block with 2mg magnesium sulphate 10% as an adjuvant to 20mg of bupivacaine 0.25% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Patients aged 18 years or more.
Key exclusion criteria (4 listed)
- • Patient refusal of peripheral nerve block
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 |
|---|---|---|
| Pericapsular nerve group block using bupivicaine and magnesium sulphateThis technique involves the deposition of the local anesthetic in the fascial plane between the psoas muscle and the superior pubic ramus | Drug | Group M |
Primary outcome
Postoperative pain management
Time frame: 24 hours postoperatively
total amount of postoperative morphine consumption in the first 24 hours postoperatively.
1 secondary outcome
Visual analog scale
Time frame: 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
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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.
Alaa M Attia, Professor study chair
Assiut University
Fatma A Abd Diab, Associate Professor study director
South Egypt's cancer institute, Assiut University
Moaz Tohamy, Lecturer study director
South Egypt's cancer institute, Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pericapsular nerve group block using bupivicaine and magnesium sulphate in people with Hip Fractures, run by Assiut 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 3 inclusion and 4 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 22 Dec 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Mustafa M Bekhet, MBBCH (+201060286688, mustafabekhet708@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain management (time frame: 24 hours postoperatively). 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 22 Dec 2023.