Difference in Reduction in Visual Analogue Score at 30 MinutesNCT06631118
Pericapsular Nerve Block Versus Propofol During Hip Fractures Surgery
A study testing pericapsular nerve group block for group A,low dose intravenous Propofol [0.7mg/kg] over 30 seconds for group B in people with Difference in Reduction in Visual Analogue Score at 30 Minutes, run by Ain Shams University.
Trial summary
The study will compare the efficacy of Pericapsular nerve group block (PENG) versus low dose Propofol for the achievement of painless sitting position before spinal anesthesia in patients undergoing repair of Hip fractures. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Difference in Reduction in Visual Analogue Score at 30 Minutes
- What is being tested?
- pericapsular nerve group block for group A,low dose intravenous Propofol [0.7mg/kg] over 30 seconds for group B
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 21 Oct 2024to 15 Feb 2025
- 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
- All patients in the age group ranging 40-70, both genders, belonging to physical status American Society of Anaesthesiologists (ASA) I and II
Who cannot join
- Patients with old fractures (more than 7 days), polytrauma, bleeding disorders or coagulopathy, local site infection, difficulty expressing pain scores such as hearing disability, mentally challenged, dementia or psychiatric illness and who refused to take part
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pericapsular Nerve Group (PENG) Block Versus Low Dose Propofol to Achieve Painless Sitting Position Before Spinal Anesthesia in Patients With Hip Fractures
The study will compare the efficacy of Pericapsular nerve group block (PENG) versus low dose Propofol for the achievement of painless sitting position before spinal anesthesia in patients undergoing repair of Hip fractures.
- Being tested
- pericapsular nerve group block for group A,low dose intravenous Propofol [0.7mg/kg] over 30 seconds for group B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pericapsular nerve group block for group A,low dose intravenous Propofol [0.7mg/kg] over 30 seconds for group BProcedure or surgery
Patients in group A will receive ultrasound guided pericapsular nerve group block (PENG) while patients in group B will receive low dose intravenous Propofol0.7mg/kg] over 30 seconds followed by spinal anesthesia in both groups
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group (A ) : will receive ultrasound guided pericapsular nerve group block (PENG) followed by spinal anesthesia. Receives: Procedure: pericapsular nerve group block for group A,low dose intravenous Propofol [0.7mg/kg] over 30 seconds for group B |
| Group B | Active comparator | Group B will receive low dose intravenous Propofol [0.7mg/kg] over 30 seconds followed by spinal anesthesia and so far, this is the most common and standard technique to achieve sitting position during spinal anesthesia for patients with hip fractures. Receives: Procedure: pericapsular nerve group block for group A,low dose intravenous Propofol [0.7mg/kg] over 30 seconds for group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in VAS scale
The primary outcome will be difference in median reduction in VAS-D .
Measured: 30 min after giving propofol and the PENG block.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start21 Oct 2024 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion15 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difference in Reduction in Visual Analogue Score at 30 MinutesStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Emam, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631118
- Sponsor's protocol ID
- FMASU R 130/2024
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericapsular Nerve Group (PENG) Block Versus Low Dose Propofol to Achieve Painless Sitting Position Before Spinal Anesthesia in Patients With Hip Fractures
- ClinicalTrials.gov ID
- NCT06631118
- Acronym / sponsor ID
- FMASU R 130/2024
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 21 Oct 2024 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 8 Oct 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.
The study will compare the efficacy of Pericapsular nerve group block (PENG) versus low dose Propofol for the achievement of painless sitting position before spinal anesthesia in patients undergoing repair of Hip fractures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: pericapsular nerve group block for group A,low dose intravenous Propofol [0.7mg/kg] over 30 seconds for group BGroup (A ) : will receive ultrasound guided pericapsular nerve group block (PENG) followed by spinal anesthesia. |
| Group B | Active comparator | Procedure: pericapsular nerve group block for group A,low dose intravenous Propofol [0.7mg/kg] over 30 seconds for group BGroup B will receive low dose intravenous Propofol [0.7mg/kg] over 30 seconds followed by spinal anesthesia and so far, this is the most common and standard technique to achieve sitting position during spinal anesthesia for patients with hip fractures. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients in the age group ranging 40-70, both genders, belonging to physical status American Society of Anaesthesiologists (ASA) I and II
Key exclusion criteria (1 listed)
- Patients with old fractures (more than 7 days), polytrauma, bleeding disorders or coagulopathy, local site infection, difficulty expressing pain scores such as hearing disability, mentally challenged, dementia or psychiatric illness and who refused to take part
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 for group A,low dose intravenous Propofol [0.7mg/kg] over 30 seconds for group BPatients in group A will receive ultrasound guided pericapsular nerve group block (PENG) while patients in group B will receive low dose intravenous Propofol0.7mg/kg] over 30 seconds followed by spinal anesthesia in both groups | Procedure or surgery | Group A, Group B |
Primary outcome
The difference in VAS scale
Time frame: 30 min after giving propofol and the PENG block.
The primary outcome will be difference in median reduction in VAS-D .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: Yes. Study protocol
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.
Questions about this trial
What is this clinical trial studying?
A study testing pericapsular nerve group block for group A,low dose intravenous Propofol [0.7mg/kg] over 30 seconds for group B in people with Difference in Reduction in Visual Analogue Score at 30 Minutes, run by Ain Shams University.
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 8 Oct 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?
Contact Marwa Mamdouh Mohamed (01000205686 ext. 002, marwaemam600@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in VAS scale (time frame: 30 min after giving propofol and the PENG block.). 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 8 Oct 2024.