Hip FracturesPhase 1NCT06294665
Comparison Between Bupivacaine-Dexmedetomidine Versus Bupivacaine-Dexamethasone in Pericapsular Nerve Group (PENG) Block
A Phase 1 study testing Pericapsular Nerve Group (PENG) Block in people with Hip Fractures and Post Operative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this work is to compare the effectiveness of bupivacaine- dexmedetomidine mixture versus bupivacaine-dexamethasone mixture in PENG Block as Post-operative Analgesia in Hip surgeries Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures, Post Operative Pain
- What is being tested?
- Pericapsular Nerve Group (PENG) Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Jan 2025
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years.
- Sex: Both sexes.
- American Society of Anaesthesiologists (ASA) Physical Status Class I and II.
- Scheduled for hip surgeries under spinal anaesthesia.
Who cannot join
- Declining to give written informed consent.
- History of allergy to the medications used in the study.
- Contraindications to regional anesthesia (including patient refusal, coagulopathy and local infection).
- Psychiatric disorder.
- American Society of Anesthesiologists (ASA) Physical Status Class III and IV.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, 11122
Fatma Ebeid, +201095569596, dr.fatma_ebeid@yahoo.com
Mohamed Salama
About this study
Official title: Comparison Between Bupivacaine-Dexmedetomidine Versus Bupivacaine-Dexamethasone in Pericapsular Nerve Group (PENG) Block as Post-operative Analgesia in Hip Surgeries.
The aim of this work is to compare the effectiveness of bupivacaine- dexmedetomidine mixture versus bupivacaine-dexamethasone mixture in PENG Block as Post-operative Analgesia in Hip surgeries
- Conditions
- Hip Fractures, Post Operative Pain
- Being tested
- Pericapsular Nerve Group (PENG) Block
- Medical subject headings
- Hip Fractures, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular Nerve Group (PENG) BlockDrug
The PENG block will be performed ,the patient is placed in the supine position , the procedural leg is slightly abducted, the curvilinear low-frequency ultrasound probe will be placed over the line parallel to the inguinal ligament. It will subsequently rotated 45◦ to identify the anterior inferior iliac spine, the iliopubic eminence, and the psoas tendon. A 22-gauge, 80 mm echogenic needle will inserted in an in-plane approach to place the tip in the musculofascial plane between the pubic ramus posteriorly and the psoas tendon anteriorly. Following negative aspiration, by one of the two syringes each one has a serial number corresponding to each group.
| Study group | Role | What they receive |
|---|---|---|
| Group A : ( Bupivacaine + Dexmedetomidine ) | Active comparator | Group A : will receive bupivacaine 0.25% + dexmedetomidine 1 mic/kg, total volume (20 ml) Receives: Drug: Pericapsular Nerve Group (PENG) Block |
| Group B: ( Bupivacaine + Dexamethasone ) | Active comparator | Group B : will receive bupivacaine 0.25% +dexamethasone (8 mg), total volume(20 ml). Receives: Drug: Pericapsular Nerve Group (PENG) Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to the first request of analgesia
The time interval between the onset of the local infiltration done at the end of the operation and the first request to postoperative analgesia.
Measured: 9 months
Secondary outcomes (2)
Total doses of analgesia (Nalbuphine) given to patients in 24 hours postoperatively
Measured: 9 months
Occurrence of side effects of drugs.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jan 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 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294665
- Sponsor's protocol ID
- MD113/2023
- Status last verified
- Feb 2024
- First submitted
- 28 Feb 2024
- Last updated
- 5 Mar 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 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Bupivacaine-Dexmedetomidine Versus Bupivacaine-Dexamethasone in Pericapsular Nerve Group (PENG) Block as Post-operative Analgesia in Hip Surgeries.
- ClinicalTrials.gov ID
- NCT06294665
- Acronym / sponsor ID
- MD113/2023
- Conditions
- Hip Fractures, Post Operative Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 5 Mar 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 aim of this work is to compare the effectiveness of bupivacaine- dexmedetomidine mixture versus bupivacaine-dexamethasone mixture in PENG Block as Post-operative Analgesia in Hip surgeries
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A : ( Bupivacaine + Dexmedetomidine ) | Active comparator | Drug: Pericapsular Nerve Group (PENG) BlockGroup A : will receive bupivacaine 0.25% + dexmedetomidine 1 mic/kg, total volume (20 ml) |
| Group B: ( Bupivacaine + Dexamethasone ) | Active comparator | Drug: Pericapsular Nerve Group (PENG) BlockGroup B : will receive bupivacaine 0.25% +dexamethasone (8 mg), total volume(20 ml). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years.
- Sex: Both sexes.
- American Society of Anaesthesiologists (ASA) Physical Status Class I and II.
- Scheduled for hip surgeries under spinal anaesthesia.
Key exclusion criteria (5 listed)
- Declining to give written informed consent.
- History of allergy to the medications used in the study.
- Contraindications to regional anesthesia (including patient refusal, coagulopathy and local infection).
- Psychiatric disorder.
- American Society of Anesthesiologists (ASA) Physical Status Class III and IV.
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 (PENG) BlockThe PENG block will be performed ,the patient is placed in the supine position , the procedural leg is slightly abducted, the curvilinear low-frequency ultrasound probe will be placed over the line parallel to the inguinal ligament. It will subsequently rotated 45◦ to identify the anterior inferior iliac spine, the iliopubic eminence, and the psoas tendon. A 22-gauge, 80 mm echogenic needle will inserted in an in-plane approach to place the tip in the musculofascial plane between the pubic ramus posteriorly and the psoas tendon anteriorly. Following negative aspiration, by one of the two syringes each one has a serial number corresponding to each group. | Drug | Group A : ( Bupivacaine + Dexmedetomidine ), Group B: ( Bupivacaine + Dexamethasone ) |
Primary outcome
The time to the first request of analgesia
Time frame: 9 months
The time interval between the onset of the local infiltration done at the end of the operation and the first request to postoperative analgesia.
2 secondary outcomes
Total doses of analgesia (Nalbuphine) given to patients in 24 hours postoperatively
Time frame: 9 months
Occurrence of side effects of drugs.
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pericapsular Nerve Group (PENG) Block in people with Hip Fractures and Post Operative Pain, run by Ain Shams 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 4 inclusion and 5 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 5 Mar 2024. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Mohamed AA Salama (+201006206630, m_adel92@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to the first request of analgesia (time frame: 9 months). 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 5 Mar 2024.