Proximal Femur FractureNCT06989047
Ultrasound-Guided PENG Block vs Femoral Nerve Block for Analgesia Before Spinal Anesthesia in Hip Fracture Surgery
A study testing Pericapsular Nerve Group (PENG) Block and Femoral Nerve Block (FNB) in people with Proximal Femur Fracture and Hip Fracture, run by Ain Shams University.
Trial summary
This study will compare two types of ultrasound-guided nerve blocks-Pericapsular Nerve Group (PENG) block and Femoral Nerve Block (FNB)-to evaluate their effectiveness in reducing pain before spinal anesthesia in patients who will undergo surgery for proximal femur fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Femur Fracture, Hip Fracture, Pain Management
- What is being tested?
- Pericapsular Nerve Group (PENG) Block and Femoral Nerve Block (FNB)
- Type of treatment
- 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
- 30 May 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Scheduled for proximal femur fracture fixation under spinal anesthesia
- Classified as American Society of Anesthesiologists (ASA) physical status I, II, or III
- Ability to understand and use the Visual Analog Scale (VAS)
- Provided written informed consent
Who cannot join
- Coagulopathy
- Local infection at the injection site
- Known allergy to local anesthetics or magnesium sulfate
- Severe cardiopulmonary disease [American Society of Anesthesiologists (ASA) ≥ IV]
- Preexisting diabetic or other neuropathies
- Chronic opioid use
- Contraindication to spinal anesthesia
- Cognitive impairment or inability to comprehend Visual Analog Scale (VAS)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Study of Preoperative Ultrasound-Guided Pericapsular Nerve Group Block and Femoral Nerve Block for Analgesia Before Spinal Anesthesia in Proximal Femur Fracture Fixation
This study will compare two types of ultrasound-guided nerve blocks-Pericapsular Nerve Group (PENG) block and Femoral Nerve Block (FNB)-to evaluate their effectiveness in reducing pain before spinal anesthesia in patients who will undergo surgery for proximal femur fractures. Proximal femur fractures will continue to be common, especially in older adults, and often will cause severe pain that will make it difficult to position patients for spinal anesthesia. Both nerve blocks will aim to reduce pain, improve comfort during spinal anesthesia, and decrease the need for postoperative pain medication.
A total of 60 adult patients who will undergo proximal femur fracture fixation under spinal anesthesia will be enrolled and randomly assigned to receive either a Pericapsular Nerve Group (PENG) block or a femoral nerve block before the procedure. The study will monitor patients' pain scores using the Visual Analog Scale (VAS) at multiple time points, including during positioning and throughout the first 24 hours after surgery. It also will evaluate how long it will take before the patients require rescue pain medication, and how much total pain medication will be needed.
- Being tested
- Pericapsular Nerve Group (PENG) Block, Femoral Nerve Block (FNB)
- Keywords
- Pericapsular Nerve Group Block (PENG), Femoral Nerve Block (FNB), Ultrasound-Guided Nerve Block, Spinal Anesthesia, Hip Surgery, Regional Anesthesia
- Medical subject headings
- Proximal Femoral Fractures, Hip Fractures, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular Nerve Group (PENG) BlockProcedure or surgery
Assigned Interventions:
Procedure/Surgery: Pericapsular Nerve Group (PENG) Block An ultrasound-guided nerve block targeting articular branches of the femoral, obturator, and accessory obturator nerves. Performed under aseptic technique using a curved low-frequency ultrasound probe to visualize the iliopsoas plane and pubic ramus.
Drug: Bupivacaine (0.25%, 30 ml) Local anesthetic used to provide analgesia in nerve block. Drug: Magnesium sulfate (10%, 5 ml = 500 mg) Adjunct used to enhance analgesic efficacy of the block.
Femoral Nerve Block (FNB)Procedure or surgery
An ultrasound-guided nerve block targeting the femoral nerve to provide analgesia before spinal anesthesia in proximal femur fracture surgery. Administered using 30 ml of 0.25% bupivacaine and 5 ml of 10% magnesium sulfate (500 mg). The block is performed with an in-plane ultrasound approach, identifying the femoral nerve lateral to the femoral artery under sterile conditions.
| Study group | Role | What they receive |
|---|---|---|
| PENG Block Group | Experimental | Assigned Interventions:
Procedure/Surgery: Pericapsular Nerve Group (PENG) Block An ultrasound-guided nerve block targeting articular branches of the femoral, obturator, and accessory obturator nerves. Performed under aseptic technique using a curved low-frequency ultrasound probe to visualize the iliopsoas plane and pubic ramus.
Drug: Bupivacaine (0.25%, 30 ml) Local anesthetic used to provide analgesia in nerve block. Drug: Magnesium sulfate (10%, 5 ml = 500 mg) Adjunct used to enhance analgesic efficacy of the block. Receives: Procedure: Pericapsular Nerve Group (PENG) Block |
| Femoral Nerve Block Group | Active comparator | Assigned Interventions:
Procedure/Surgery: Femoral Nerve Block (FNB) An ultrasound-guided nerve block targeting the femoral nerve, performed with an in-plane ultrasound approach under sterile conditions, identifying the nerve lateral to the femoral artery.
Drug: Bupivacaine (0.25%, 30 ml) Local anesthetic used for nerve block. Drug: Magnesium sulfate (10%, 5 ml = 500 mg) Adjunct analgesic agent. Receives: Procedure: Femoral Nerve Block (FNB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score During Positioning for Spinal Anesthesia Using Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) will be used to assess pain intensity during positioning for spinal anesthesia. The VAS is a 10 cm line where 0 indicates no pain and 10 indicates the worst imaginable pain. The score will be recorded immediately before spinal anesthesia after performing either the PENG block or femoral nerve block.
Measured: Immediately before spinal anesthesia (within 15 minutes post-block)
Time to First Rescue Analgesia
The time (in hours) from the end of the nerve block to the first request for additional analgesia (nalbuphine 0.2 mg/kg IV) will be recorded for each patient.
Measured: Within 24 hours postoperatively
Secondary outcomes (3)
Total Nalbuphine Consumption
The cumulative dose (in mg) of intravenous nalbuphine administered for pain control will be calculated for each participant over the first 24 hours following surgery.
Measured: 24 hours postoperatively
Mean Arterial Pressure (MAP) Changes
Mean arterial pressure will be recorded at baseline (pre-block), then at 2, 5, 10, 15 minutes post-block, and subsequently at 2, 6, 12, 18, and 24 hours after surgery to evaluate hemodynamic stability following either pericapsular nerve block (PENG) block or femoral nerve block.
Measured: From baseline up to 24 hours postoperatively
Patient Satisfaction Score
Patient satisfaction with pain control will be evaluated using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied) at the end of the 24-hour postoperative period.
Measured: At 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 posted25 May 2025
- Study start30 May 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Femur FractureStudies 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
- 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
- Principal investigator, Mohamed Khaled Radwan Ammar, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989047
- Sponsor's protocol ID
- FMASU MS49/2024
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Preoperative Ultrasound-Guided Pericapsular Nerve Group Block and Femoral Nerve Block for Analgesia Before Spinal Anesthesia in Proximal Femur Fracture Fixation
- ClinicalTrials.gov ID
- NCT06989047
- Acronym / sponsor ID
- FMASU MS49/2024
- Keywords
- Pericapsular Nerve Group Block (PENG), Femoral Nerve Block (FNB), Ultrasound-Guided Nerve Block, Spinal Anesthesia, Hip Surgery, Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 May 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 25 May 2025 (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.
This study will compare two types of ultrasound-guided nerve blocks-Pericapsular Nerve Group (PENG) block and Femoral Nerve Block (FNB)-to evaluate their effectiveness in reducing pain before spinal anesthesia in patients who will undergo surgery for proximal femur fractures. Proximal femur fractures will continue to be common, especially in older adults, and often will cause severe pain that will make it difficult to position patients for spinal anesthesia. Both nerve blocks will aim to reduce pain, improve comfort during spinal anesthesia, and decrease the need for postoperative pain medication.
A total of 60 adult patients who will undergo proximal femur fracture fixation under spinal anesthesia will be enrolled and randomly assigned to receive either a Pericapsular Nerve Group (PENG) block or a femoral nerve block before the procedure. The study will monitor patients' pain scores using the Visual Analog Scale (VAS) at multiple time points, including during positioning and throughout the first 24 hours after surgery. It also will evaluate how long it will take before the patients require rescue pain medication, and how much total pain medication will be needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG Block Group | Experimental | Procedure: Pericapsular Nerve Group (PENG) BlockAssigned Interventions: Procedure/Surgery: Pericapsular Nerve Group (PENG) Block An ultrasound-guided nerve block targeting articular branches of the femoral, obturator, and accessory obturator nerves. Performed under aseptic technique using a curved low-frequency ultrasound probe to visualize the iliopsoas plane and pubic ramus. Drug: Bupivacaine (0.25%, 30 ml) Local anesthetic used to provide analgesia in nerve block. Drug: Magnesium sulfate (10%, 5 ml = 500 mg) Adjunct used to enhance analgesic efficacy of the block. |
| Femoral Nerve Block Group | Active comparator | Procedure: Femoral Nerve Block (FNB)Assigned Interventions: Procedure/Surgery: Femoral Nerve Block (FNB) An ultrasound-guided nerve block targeting the femoral nerve, performed with an in-plane ultrasound approach under sterile conditions, identifying the nerve lateral to the femoral artery. Drug: Bupivacaine (0.25%, 30 ml) Local anesthetic used for nerve block. Drug: Magnesium sulfate (10%, 5 ml = 500 mg) Adjunct analgesic agent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Scheduled for proximal femur fracture fixation under spinal anesthesia
- Classified as American Society of Anesthesiologists (ASA) physical status I, II, or III
- Ability to understand and use the Visual Analog Scale (VAS)
- Provided written informed consent
Key exclusion criteria (8 listed)
- Coagulopathy
- Local infection at the injection site
- Known allergy to local anesthetics or magnesium sulfate
- Severe cardiopulmonary disease [American Society of Anesthesiologists (ASA) ≥ IV]
- Preexisting diabetic or other neuropathies
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) BlockAssigned Interventions: Procedure/Surgery: Pericapsular Nerve Group (PENG) Block An ultrasound-guided nerve block targeting articular branches of the femoral, obturator, and accessory obturator nerves. Performed under aseptic technique using a curved low-frequency ultrasound probe to visualize the iliopsoas plane and pubic ramus. Drug: Bupivacaine (0.25%, 30 ml) Local anesthetic used to provide analgesia in nerve block. Drug: Magnesium sulfate (10%, 5 ml = 500 mg) Adjunct used to enhance analgesic efficacy of the block. | Procedure or surgery | PENG Block Group |
| Femoral Nerve Block (FNB)An ultrasound-guided nerve block targeting the femoral nerve to provide analgesia before spinal anesthesia in proximal femur fracture surgery. Administered using 30 ml of 0.25% bupivacaine and 5 ml of 10% magnesium sulfate (500 mg). The block is performed with an in-plane ultrasound approach, identifying the femoral nerve lateral to the femoral artery under sterile conditions. | Procedure or surgery | Femoral Nerve Block Group |
Primary outcome
Pain Score During Positioning for Spinal Anesthesia Using Visual Analog Scale (VAS)
Time frame: Immediately before spinal anesthesia (within 15 minutes post-block)
The Visual Analog Scale (VAS) will be used to assess pain intensity during positioning for spinal anesthesia. The VAS is a 10 cm line where 0 indicates no pain and 10 indicates the worst imaginable pain. The score will be recorded immediately before spinal anesthesia after performing either the PENG block or femoral nerve block.
Time to First Rescue Analgesia
Time frame: Within 24 hours postoperatively
The time (in hours) from the end of the nerve block to the first request for additional analgesia (nalbuphine 0.2 mg/kg IV) will be recorded for each patient.
3 secondary outcomes
Total Nalbuphine Consumption
Time frame: 24 hours postoperatively
Mean Arterial Pressure (MAP) Changes
Time frame: From baseline up to 24 hours postoperatively
Patient Satisfaction Score
Time frame: At 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pericapsular Nerve Group (PENG) Block and Femoral Nerve Block (FNB) in people with Proximal Femur Fracture and Hip Fracture, 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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 25 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed K Ammar, M.B.B.Ch (01153702277 ext. +2, Mohamed_Khaled@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score During Positioning for Spinal Anesthesia Using Visual Analog Scale (VAS) (time frame: Immediately before spinal anesthesia (within 15 minutes post-block)). 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 25 May 2025.