Pericapsular Nerve Group BlockNCT06577103
The Analgesic Effect of Pericapsular Nerve Group Block With Lateral Femoral Cutaneous Nerve Block and Pericapsular Nerve Group Block With Supra-inguinal Fascia Iliaca Block in Hip Hemiarthroplasty
A study testing Pericapsular nerve group block (PENG) with supra-inguinal fascia iliaca block (SIFIC) and Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve block (LFCN) in people with Pericapsular Nerve Group Block and Lateral Femoral Cutaneous Nerve Block, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to investigate the efficiency of preoperative and post-operative analgesia by pericapsular nerve group block (PENG) block with supra-inguinal fascia iliaca block (SIFIC) block compared with PENG block with lateral femoral cutaneous nerve block (LFCN) block in ease of giving a sitting position… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pericapsular Nerve Group Block, Lateral Femoral Cutaneous Nerve Block, Supra-inguinal Fascia Iliaca Block
- What is being tested?
- Pericapsular nerve group block (PENG) with supra-inguinal fascia iliaca block (SIFIC) and Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve block (LFCN)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2024to 1 Dec 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-80 years.
- Sex: Both sexes.
- American Society of Anaesthesiologists (ASA) Physical Status Class I, II, and III.
- Scheduled for hip hemiarthroplasty under general anesthesia.
Who cannot join
- Declining to give a 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 disorders or narcotic abusers.
- Significant cognitive dysfunction.
- American Society of Anesthesiologists (ASA) Physical Status Class IV.
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- Renal insufficiency (to avoid local anesthetic or nalbuphine metabolites adverse effect)
- Opioid abuser patients
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between the Analgesic Effect of Pericapsular Nerve Group Block (PENG) With Lateral Femoral Cutaneous Nerve Block (LFCN) and Pericapsular Nerve Group Block (PENG) With Supra-inguinal Fascia Iliaca Block (SIFIC) in Hip Hemiarthroplasty: a Prospective Randomized Clinical Trial
The aim of this study is to investigate the efficiency of preoperative and post-operative analgesia by pericapsular nerve group block (PENG) block with supra-inguinal fascia iliaca block (SIFIC) block compared with PENG block with lateral femoral cutaneous nerve block (LFCN) block in ease of giving a sitting position for spinal anesthesia and reducing narcotic consumption during the first 24 hour post-operatively and functional recovary by using the Visual analogue scale (VAS) of pain.
Read the detailed description
The established practice to decrease pain using opioids in hip fracture surgery may result in compromised outcomes in the frail and elderly population with nausea-vomiting, constipation, delirium and respiratory depression. This popularized the regional analgesic techniques in the surgical treatment of hip fractures. Femoral nerve (FN) and supra-inguinal fascia iliaca block (SIFIC) block are documented to provide good peri-operative analgesia with reduced need for opioids.
The latest pericapsular nerve group block (PENG) block, is an interfacial plane block targeting the articular branches of the femoral, obturator (ON) and accessory obturator nerves (AON) at the hip.
An ability to perform in supine positioning, which is especially important in patients with acute hip fractures or chronic pain is an indigenous advantage of PENG block. Due to the blockade of only sensory articular branches, substantial motor weakness is unexpected. But exclusive use of PENG block for analgesia in hip fracture patients is not sufficient as it doesn't involve the cutaneous pain-generating area supplied by the lateral femoral cutaneous nerve block (LFCN).
- Conditions
- Pericapsular Nerve Group Block, Lateral Femoral Cutaneous Nerve Block, Supra-inguinal Fascia Iliaca Block, Hip Hemiarthroplasty
- Being tested
- Pericapsular nerve group block (PENG) with supra-inguinal fascia iliaca block (SIFIC), Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve block (LFCN)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular nerve group block (PENG) with supra-inguinal fascia iliaca block (SIFIC)Other
Patients will receive pericapsular nerve group (PENG) block with supra-inguinal fascia iliaca (SIFIC) block.
Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve block (LFCN)Other
Patients will receive pericapsular nerve group (PENG) block with lateral femoral cutaneous nerve (LFCN) block.
| Study group | Role | What they receive |
|---|---|---|
| Pericapsular nerve group block (PENG) with supra-inguinal fascia iliaca block (SIFIC) | Experimental | Patients will receive pericapsular nerve group (PENG) block with supra-inguinal fascia iliaca (SIFIC) block. Receives: Other: Pericapsular nerve group block (PENG) with supra-inguinal fascia iliaca block (SIFIC) |
| Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve block (LFCN) | Experimental | Patients will receive pericapsular nerve group (PENG) block with lateral femoral cutaneous nerve (LFCN) block. Receives: Other: Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve block (LFCN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
Degree of pain will be assessed by visual analogue score (VAS). VAS ranging from 0 to 10, where 0 is no pain and 10 is maximum pain. It will be assessed preoperatively first after the block application then postoperatively, at post anesthesia care unit (PACU) and then 2, 6 ,12 ,18 ,24 hours postoperatively.
Measured: 24 hours postoperatively
Secondary outcomes (4)
The ease of giving a sitting position for spinal anesthesia (EOSP)
The ease of giving a sitting position for spinal anesthesia (EOSP) will be assessed by the EOSP score .EOSP was assessed on the scale of 0-3 (0 = unable to position, 1 = patient had abnormal posturing due to pain and required support for positioning, 2 = mild discomfort but does not require support for positioning, 3 = optimal condition where the patient was able to position himself
Measured: Intraoperatively
The total dose of nalbuphine consumption
When visual analogue score (VAS) >/=4, patients will receive injection nalbuphine 10 mg/70 kg (with maximum dose 160 mg over 24 hours) intravenously.
Measured: 24 hours postoperatively
The number of patients who needed rescue analgesia
Number of patients who needed rescue analgesia will be recorded
Measured: 24 hours postoperatively
Ablility to walk with support within 24 hours
The ability of patients to walk with support will be recorded
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 posted29 Aug 2024
- Study start2 Jan 2024
- Primary completion1 Oct 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pericapsular Nerve Group BlockStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moussa Elsayed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577103
- Sponsor's protocol ID
- FMASU MD345/2023
- Status last verified
- May 2025
- First submitted
- 27 Aug 2024
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between the Analgesic Effect of Pericapsular Nerve Group Block (PENG) With Lateral Femoral Cutaneous Nerve Block (LFCN) and Pericapsular Nerve Group Block (PENG) With Supra-inguinal Fascia Iliaca Block (SIFIC) in Hip Hemiarthroplasty: a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06577103
- Acronym / sponsor ID
- FMASU MD345/2023
- Conditions
- Pericapsular Nerve Group Block, Lateral Femoral Cutaneous Nerve Block, Supra-inguinal Fascia Iliaca Block, Hip Hemiarthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 29 Aug 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 study is to investigate the efficiency of preoperative and post-operative analgesia by pericapsular nerve group block (PENG) block with supra-inguinal fascia iliaca block (SIFIC) block compared with PENG block with lateral femoral cutaneous nerve block (LFCN) block in ease of giving a sitting position for spinal anesthesia and reducing narcotic consumption during the first 24 hour post-operatively and functional recovary by using the Visual analogue scale (VAS) of pain.
Detailed description
The established practice to decrease pain using opioids in hip fracture surgery may result in compromised outcomes in the frail and elderly population with nausea-vomiting, constipation, delirium and respiratory depression. This popularized the regional analgesic techniques in the surgical treatment of hip fractures. Femoral nerve (FN) and supra-inguinal fascia iliaca block (SIFIC) block are documented to provide good peri-operative analgesia with reduced need for opioids.
The latest pericapsular nerve group block (PENG) block, is an interfacial plane block targeting the articular branches of the femoral, obturator (ON) and accessory obturator nerves (AON) at the hip.
An ability to perform in supine positioning, which is especially important in patients with acute hip fractures or chronic pain is an indigenous advantage of PENG block. Due to the blockade of only sensory articular branches, substantial motor weakness is unexpected. But exclusive use of PENG block for analgesia in hip fracture patients is not sufficient as it doesn't involve the cutaneous pain-generating area supplied by the lateral femoral cutaneous nerve block (LFCN).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pericapsular nerve group block (PENG) with supra-inguinal fascia iliaca block (SIFIC) | Experimental | Other: Pericapsular nerve group block (PENG) with supra-inguinal fascia iliaca block (SIFIC)Patients will receive pericapsular nerve group (PENG) block with supra-inguinal fascia iliaca (SIFIC) block. |
| Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve block (LFCN) | Experimental | Other: Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve block (LFCN)Patients will receive pericapsular nerve group (PENG) block with lateral femoral cutaneous nerve (LFCN) block. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 40-80 years.
- Sex: Both sexes.
- American Society of Anaesthesiologists (ASA) Physical Status Class I, II, and III.
- Scheduled for hip hemiarthroplasty under general anesthesia.
Key exclusion criteria (9 listed)
- Declining to give a 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 disorders or narcotic abusers.
- Significant cognitive dysfunction.
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 (PENG) with supra-inguinal fascia iliaca block (SIFIC)Patients will receive pericapsular nerve group (PENG) block with supra-inguinal fascia iliaca (SIFIC) block. | Other | Pericapsular nerve group block (PENG) with supra-inguinal fascia iliaca block (SIFIC) |
| Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve block (LFCN)Patients will receive pericapsular nerve group (PENG) block with lateral femoral cutaneous nerve (LFCN) block. | Other | Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve block (LFCN) |
Primary outcome
Degree of pain
Time frame: 24 hours postoperatively
Degree of pain will be assessed by visual analogue score (VAS). VAS ranging from 0 to 10, where 0 is no pain and 10 is maximum pain. It will be assessed preoperatively first after the block application then postoperatively, at post anesthesia care unit (PACU) and then 2, 6 ,12 ,18 ,24 hours postoperatively.
4 secondary outcomes
The ease of giving a sitting position for spinal anesthesia (EOSP)
Time frame: Intraoperatively
The total dose of nalbuphine consumption
Time frame: 24 hours postoperatively
The number of patients who needed rescue analgesia
Time frame: 24 hours postoperatively
Ablility to walk with support within 24 hours
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Pericapsular nerve group block (PENG) with supra-inguinal fascia iliaca block (SIFIC) and Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve block (LFCN) in people with Pericapsular Nerve Group Block and Lateral Femoral Cutaneous Nerve Block, 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 9 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: finished, as of the sponsor's last update on 2 May 2025. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Degree of pain (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 2 May 2025.