Pain, PostoperativeNCT06321718
Pericapsular Nerve Group Block vs Supra Inguinal Fascia Iliaca Compartment Block
A study testing PENG + LFCN block versus S-FICB in people with Pain, Postoperative, run by Assiut University at 1 site in Egypt.
Trial summary
This study aims to assess the efficacy of PENG block performed with LFCN block in controlling postoperative pain and promoting motor function recovery and to compare its effectiveness with S-FICB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- PENG + LFCN block versus S-FICB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 1 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All hip trauma patients ≥ 18 years' old
- ASA class I, II, and III
- Solitary hip fracture
Who cannot join
- Neurological disturbance either baseline or traumatic brain injury
- Contraindications for regional anesthesia as bleeding disorders, infection at site of injection, or hypersensitivity to the used local anesthetics.
- Patient refusal.
- Massive poly trauma.
- Uncooperative patient
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut university, faculty of medicine
Asyut, Asyut Governorate, 71515
About this study
Official title: Comparison Between Pericapsular Nerve Group (PENG) Block With Lateral Femoral Cutaneous Nerve Block and Supra Inguinal Fascia Iliaca Compartment Block (S FICB) for Traumatic Hip Fixation Surgeries: a Randomized Controlled Trial
This study aims to assess the efficacy of PENG block performed with LFCN block in controlling postoperative pain and promoting motor function recovery and to compare its effectiveness with S-FICB.
Read the detailed description
96 Patients will be assessed thoroughly for history (to exclude previous medical history, previous anesthesia, with/without perioperative complications, smoking status, cardiorespiratory disorders or bleeding disorders), examination (for the full primary and secondary trauma survey to exclude any coexisting trauma that threatens patient life, laboratory (for CBC, bleeding tendencies, serology, kidney dysfunction and availability of blood transfusion) and radiological (for cardiac assessment, and exclusion of other trauma). ASA score then to be determined. Full monitoring of the patient will be recorded, basically, HR, ECG, SpO2, NIBP, EtCO2, temperature. Peripheral vein cannula will be secured and the fluids will be infused as 10- 15ml/kg before induction of anesthesia. Choice of type of anesthesia will be established according to every individual patient, but spinal anesthesia will be preferred over general anesthesia. The block will be administered under supervision of the supervisor senior staff before induction of anesthesia. Type of the block will be randomly assigned into two groups according to website computer program randomization program to distribute cases into two groups using their order number:
- Group (A) will receive PENG + LFCN block: The low-frequency curvilinear probe (3-5 MHz) of ultrasound (GE Logiq e, GE Health care, USA) will be placed in a transverse plane over the anterior inferior iliac spine (AIIS) and aligned with the pubic ramus by rotating the probe counterclockwise to obtain a hyper-echoic bright line, which is the iliopubic eminence (IPE). In this view, the iliopsoas muscle and psoas tendon, the femoral artery, and pectineus muscle can be observed. Using the in-plane injection technique, a 22G, 80 mm insulated block needle was inserted in a lateral-to-medial direction, and the tip will then be placed between the psoas tendon anteriorly and the pubic ramus posteriorly. After no blood was drawn back, the LA (20 ml, 0.25% bupivacaine) will be injected to get an image of the psoas tendon uplifted. After the PENG block is performed, a high-frequency linear probe (6-12 MHz) will be placed on the inguinal ligament to get a short-axial view of femoral artery, then the probe is moved laterally to identify the sartorius muscle, the tail of the probe will be positioned toward the anterior superior iliac spine to observe the LFCN covered by fascia between sartorius and tensor fascia lata. After no blood can be withdrawn back, the LA (10 ml, 0.25% bupivacaine) will be injected following negative aspiration
- The second group (B): S-FICB: A high-frequency linear probe (6-12 MHz) of ultrasound (GE Logiq e, GE Healthcare, USA) will be used. The probe is placed adjacent to the inguinal ligament with its long axis parallel to the ligament. After the femoral artery and the femoral nerve will be observed, the probe will be moved laterally to identify the sartorius muscle and placing it at the center of the screen. Then the probe will be moved cephalically to the anterior superior iliac spine (ASIS) until the image of the sartorius muscle will disappear, and the medial side of ASIS was identifed as the iliacus muscle. Next, by rotating the medial end of the ultrasound probe toward the umbilicus, the ASIS, iliac bone, and abdominal muscles will be observed on the screen. Using the in-plane technique, a 22G, 80 mm insulated block needle will be inserted in a lateral-to-medial direction. When the needle tip will penetrate below the fascia iliacus, the LA (40 ml, 0.25% bupivacaine) will be injected following negative aspiration to obtain an image showing the LA spread between the iliacus muscle and the fascia iliacus.
- Conditions
- Pain, Postoperative
- Being tested
- PENG + LFCN block versus S-FICB
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG + LFCN block versus S-FICBProcedure or surgery
- Group (A) will receive PENG + LFCN block:
| Study group | Role | What they receive |
|---|---|---|
| 1. Group (A) | Experimental | will receive PENG + LFCN block |
| 2. group (B) | Experimental | will receive S-FICB |
What is being measured
The primary outcome is the main question the study is designed to answer.
recording time for "return of full muscle power"
duration between the end of surgery and the first time the patient was able to move his operated leg. The full power return will be defined as pre-operative muscle power according to manual muscle testing scale (MRC)/ Muscle Power Scale as following: Score Description 0 No contraction
- Flicker or trace of contraction
- Active movement, with gravity eliminated
- Active movement against gravity
- Active movement against gravity and resistance
- Normal power
Measured: at hour 0, 2 hours, 4 hours, 6 hours, 12 hours after procedure
Secondary outcomes (4)
• The degree of hip flexion on the operative side
- The degree of hip flexion on the operative side ( full range, mild restriction, major restriction, or completely no movement)
Measured: at 6 hours, 24 hours, and 48 hours.
• Static and dynamic pain scores.
A person rates their pain on a scale of 0 to 10 or 0 to 5. Zero means "no pain," and 5 or 10 means "the worst possible pain." These pain intensity levels may be assessed upon initial treatment, or periodically after treatment
Measured: at 6 hours, 24 hours, and 48 hours.
postoperative nausea and vomiting (PONV) scale
no nausea (0), mild nausea with no treatment need (1), moderate nausea and vomiting with need to treatment (2), severe nausea and vomiting even with treatment (3)
Measured: at 48 hours.
• The number of rescue analgesia
Times that he needs analgesic 30 mg ketorolac
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 May 2024
- Primary completion1 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 96 Patients will be enrolled. Choice of type of anesthesia will be established according to every individual patient, but spinal anesthesia will be preferred over general anesthesia. The block will be administered under supervision of the supervisor senior staff before induction of anesthesia. 2 groups well be assessed 1. Group (A) will receive PENG + LFCN block 2. The second group (B): S-FICB
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Abd El-Khalek Mohammed Glala, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321718
- Sponsor's protocol ID
- 04-2023-200629
- Status last verified
- Dec 2025
- First submitted
- 21 Feb 2024
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Pericapsular Nerve Group (PENG) Block With Lateral Femoral Cutaneous Nerve Block and Supra Inguinal Fascia Iliaca Compartment Block (S FICB) for Traumatic Hip Fixation Surgeries: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06321718
- Acronym / sponsor ID
- 04-2023-200629
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 20 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.
This study aims to assess the efficacy of PENG block performed with LFCN block in controlling postoperative pain and promoting motor function recovery and to compare its effectiveness with S-FICB.
Detailed description
96 Patients will be assessed thoroughly for history (to exclude previous medical history, previous anesthesia, with/without perioperative complications, smoking status, cardiorespiratory disorders or bleeding disorders), examination (for the full primary and secondary trauma survey to exclude any coexisting trauma that threatens patient life, laboratory (for CBC, bleeding tendencies, serology, kidney dysfunction and availability of blood transfusion) and radiological (for cardiac assessment, and exclusion of other trauma). ASA score then to be determined. Full monitoring of the patient will be recorded, basically, HR, ECG, SpO2, NIBP, EtCO2, temperature. Peripheral vein cannula will be secured and the fluids will be infused as 10- 15ml/kg before induction of anesthesia. Choice of type of anesthesia will be established according to every individual patient, but spinal anesthesia will be preferred over general anesthesia. The block will be administered under supervision of the supervisor senior staff before induction of anesthesia. Type of the block will be randomly assigned into two groups according to website computer program randomization program to distribute cases into two groups using their order number:
- Group (A) will receive PENG + LFCN block: The low-frequency curvilinear probe (3-5 MHz) of ultrasound (GE Logiq e, GE Health care, USA) will be placed in a transverse plane over the anterior inferior iliac spine (AIIS) and aligned with the pubic ramus by rotating the probe counterclockwise to obtain a hyper-echoic bright line, which is the iliopubic eminence (IPE). In this view, the iliopsoas muscle and psoas tendon, the femoral artery, and pectineus muscle can be observed. Using the in-plane injection technique, a 22G, 80 mm insulated block needle was inserted in a lateral-to-medial direction, and the tip will then be placed between the psoas tendon anteriorly and the pubic ramus posteriorly. After no blood was drawn back, the LA (20 ml, 0.25% bupivacaine) will be injected to get an image of the psoas tendon uplifted. After the PENG block is performed, a high-frequency linear probe (6-12 MHz) will be placed on the inguinal ligament to get a short-axial view of femoral artery, then the probe is moved laterally to identify the sartorius muscle, the tail of the probe will be positioned toward the anterior superior iliac spine to observe the LFCN covered by fascia between sartorius and tensor fascia lata. After no blood can be withdrawn back, the LA (10 ml, 0.25% bupivacaine) will be injected following negative aspiration
- The second group (B): S-FICB: A high-frequency linear probe (6-12 MHz) of ultrasound (GE Logiq e, GE Healthcare, USA) will be used. The probe is placed adjacent to the inguinal ligament with its long axis parallel to the ligament. After the femoral artery and the femoral nerve will be observed, the probe will be moved laterally to identify the sartorius muscle and placing it at the center of the screen. Then the probe will be moved cephalically to the anterior superior iliac spine (ASIS) until the image of the sartorius muscle will disappear, and the medial side of ASIS was identifed as the iliacus muscle. Next, by rotating the medial end of the ultrasound probe toward the umbilicus, the ASIS, iliac bone, and abdominal muscles will be observed on the screen. Using the in-plane technique, a 22G, 80 mm insulated block needle will be inserted in a lateral-to-medial direction. When the needle tip will penetrate below the fascia iliacus, the LA (40 ml, 0.25% bupivacaine) will be injected following negative aspiration to obtain an image showing the LA spread between the iliacus muscle and the fascia iliacus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 96 Patients will be enrolled. Choice of type of anesthesia will be established according to every individual patient, but spinal anesthesia will be preferred over general anesthesia. The block will be administered under supervision of the supervisor senior staff before induction of anesthesia. 2 groups well be assessed 1. Group (A) will receive PENG + LFCN block 2. The second group (B): S-FICB
| Arm | Type | Receives |
|---|---|---|
| 1. Group (A) | Experimental | –will receive PENG + LFCN block |
| 2. group (B) | Experimental | –will receive S-FICB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All hip trauma patients ≥ 18 years' old
- ASA class I, II, and III
- Solitary hip fracture
Key exclusion criteria (5 listed)
- Neurological disturbance either baseline or traumatic brain injury
- Contraindications for regional anesthesia as bleeding disorders, infection at site of injection, or hypersensitivity to the used local anesthetics.
- Patient refusal.
- Massive poly trauma.
- Uncooperative patient
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 |
|---|---|---|
| PENG + LFCN block versus S-FICB1. Group (A) will receive PENG + LFCN block: | Procedure or surgery | – |
Primary outcome
recording time for "return of full muscle power"
Time frame: at hour 0, 2 hours, 4 hours, 6 hours, 12 hours after procedure
duration between the end of surgery and the first time the patient was able to move his operated leg. The full power return will be defined as pre-operative muscle power according to manual muscle testing scale (MRC)/ Muscle Power Scale as following: Score Description 0 No contraction 1. Flicker or trace of contraction 2. Active movement, with gravity eliminated 3. Active movement against gravity 4. Active movement against gravity and resistance 5. Normal power
4 secondary outcomes
• The degree of hip flexion on the operative side
Time frame: at 6 hours, 24 hours, and 48 hours.
• Static and dynamic pain scores.
Time frame: at 6 hours, 24 hours, and 48 hours.
postoperative nausea and vomiting (PONV) scale
Time frame: at 48 hours.
• The number of rescue analgesia
Time frame: 24 hours
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 24 Dec 2025.
- Individual participant dataSharing planned: Yes
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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 PENG + LFCN block versus S-FICB in people with Pain, Postoperative, 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 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: finished, as of the sponsor's last update on 24 Dec 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?
recording time for "return of full muscle power" (time frame: at hour 0, 2 hours, 4 hours, 6 hours, 12 hours after procedure). 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 24 Dec 2025.