Post Operative PainNCT06402006
A Comparative Study Between Ultrasound Guided Erector Spinae Plane Block and Combined Ultrasound Guided Pericapsular Nerve Group and Lateral Femoral Nerve Block Following Total Hip Arthroplasty
A study testing PENG block, LFCN block and ESP block in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
The patients will be randomized into 2 equal groups by a computer-generated random numbers table, named group A, B. Group A: patients will receive Pericapsular nerve group block and lateral femoral cutaneous nerve blocks. Group B: Patients will receive Erector spinae plane block. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- PENG block, LFCN block and ESP block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2024to 30 Nov 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients American Society of anesthesiologists' physical status (ASA) I to III.
- Aged 18 to 65 years.
- Both sexes.
- Patients scheduled for total hip arthroplasty.
Who cannot join
- Patient refusal
- ASA physical status III or more.
- Patients with known allergy to any of the study drugs.
- Infection at the site of injection.
- Patients with history of cardiovascular disease.
- Patients with renal disease.
Show all 12Show fewer
- Patients with hepatic disease.
- Patients with neuromuscular disease.
- Presence of any coagulopathy.
- Chronic opioid, gabapentin or pregabalin use.
- Patients with history of any psychiatric disorder.
- BMI more than 35 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Ultrasound Guided Erector Spinae Plane Block and Combined Ultrasound Guided Pericapsular Nerve Group (PENG) and Lateral Femoral Nerve Block Following Total Hip Arthroplasty
The patients will be randomized into 2 equal groups by a computer-generated random numbers table, named group A, B.
Group A: patients will receive Pericapsular nerve group block and lateral femoral cutaneous nerve blocks.
Read more
Group B: Patients will receive Erector spinae plane block.
After IV access insertion and oxygen nasal cannula application, monitoring will be applied for all patients, sedation in the form of midazolam 0.02mg/kg with or without fentanyl 0.5-1 mcg/kg will be administered to any of the patients who felt discomfort or could not tolerate the procedure.
For (Group A) PENG block will be done before spinal anesthesia.
LFCN block will be performed.
For (Group B), ESP block will be done before spinal anesthesia.
Spinal anesthesia will be chosen as the main anesthetic technique.
In postoperative period all patients will receive the same adjuvant multimodal analgesia which will be 1000 mg of paracetamol with or without 30 mg ketorolac depending on comorbidities and depending on the patients" needs.
Read the detailed description
The patients will be randomized into 2 equal groups by a computer-generated random numbers table, named group A, B.
Group A: patients will receive PENG and LFCN blocks.
Group B: Patients will receive ESP block, which will be the control group.
After obtaining approval from Ain Shams hospital academic and ethical committee, written, informed and valid consent will be taken from all participants after proper explanation of the study procedure and the expected outcome in a clear language for patients of either sex, aging from 18 to 65 years old, ASA physical status (I, II) scheduled for total hip arthroplasty surgeries.
Patients with the following criteria will be excluded from the study: Patient refusal, ASA physical status III or more, known allergy to any of the study drugs, infection at the site of injection, history of cardiovascular, renal, hepatic or neuromuscular diseases, history of any psychiatric disorder, presence of any coagulopathy, chronic opioid, gabapentin or pregabalin use, BMI more than 35 kg/m2. Patients will be randomly assigned to either both PENG and LFCN blocks and ESP block with ultrasound guidance before spinal anesthesia.
After IV access insertion and oxygen nasal cannula application, ECG (Electrocardiography), pulse oximeter, noninvasive blood pressure monitoring will be applied for all patients, sedation in the form of midazolam 0.02mg/kg with or without fentanyl 0.5-1 mcg/kg will be administered to any of the patients who felt discomfort or could not tolerate the procedure.
For (Group A) PENG block will be done before spinal anesthesia ultrasound-guided using a curvilinear array ultrasound transducer (2-5 MHz) Sono site M-turbo ultrasonography. While the patient is in the supine position, the probe will be placed in parallel to the inguinal crease and will be rotated clockwise until visualizing femoral artery, iliopsoas muscle tendon, anterior inferior iliac spine (AIIS) and ilio-pubic eminence. 22G 80 mm needle will be inserted in plane from lateral side of probe until tip of needle touch iliopubic eminence, after negative aspiration 20 ml of bupivacaine 0.5% will be injected. Success of injection will be confirmed by fluid spreading between the iliopsoas tendon and periosteum of iliopubic eminence.
LFCN block will be performed using linear ultrasound probe (10-15 MHz). while the patient is in supine position the probe will be directed caudally to AIIS until visualizing LFCN between sartorius muscle and tensor fascia latae. 5 ml of bupivacaine will be injected after negative aspiration.
For (Group B), ESP block will be done before spinal anesthesia in the lateral decubitus position by curvilinear probe (2-5 MHz). Probe will be placed on the third lumber vertebra in the parasagittal line to identify the transverse process of L3. Needle will be directed in plane caudo-cephalic to the lateral edge of L3 transverse process. 30 ml of bupivacaine will be injected under visualization along the erector spinae plane. Correct placement will be defined by spread of local anesthetic cranially and caudally from injection point, dissecting the plane between the transverse processes and erector spinae muscles.
Spinal anesthesia will be chosen as the main anesthetic technique by injecting 3-3.5 ml of hyperbaric bupivacaine 0.5% by 24 G pencil-point needle at L2-L3 or L3-L4 space with 25 ug of fentanyl as adjuvant while patient is in setting position.
In postoperative period all patients will receive the same adjuvant multimodal analgesia which will be 1000 mg of paracetamol with or without 30 mg ketorolac depending on comorbidities and depending on the patients" needs.
- Conditions
- Post Operative Pain
- Being tested
- PENG block, LFCN block, ESP block
- 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 blockProcedure or surgery
pericapsular nerve group block
LFCN blockProcedure or surgery
Lateral femoral cutaneous nerve block
ESP blockProcedure or surgery
Erector spinae plane block
| Study group | Role | What they receive |
|---|---|---|
| Combined hip joint PENG block and LFCN block | Experimental | Combined hip joint pericapsular nerve group block(PENG) and lateral femoral cutaneous nerve block Receives: Procedure: PENG block; Procedure: LFCN block |
| ESP block | Experimental | Erector spinae plane block(ESP) Receives: Procedure: ESP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
individual visual analog pain scores at 0, 6, 12, 24 and 48 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).
The primary outcomes include : individual visual analog pain scores at 0, 6, 12, 24 and 48 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).
Measured: 48 hours
presence of moderate-to-severe pain, defined as pain score 4 or greater during the first 48 h postoperative.
presence of moderate-to-severe pain, defined as pain score 4 or greater during the first 48 h postoperative.
Measured: 48 hours
analgesic consumption in post-anesthesia care unit, and during the first 48 h post-surgery (converted to IV pethidine equivalents).
analgesic consumption in post-anesthesia care unit, and during the first 48 h post-surgery (converted to IV pethidine equivalents).
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start15 May 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, riham fathy galal, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402006
- Sponsor's protocol ID
- FAMSU R79/2024
- Status last verified
- May 2025
- First submitted
- 28 Apr 2024
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Ultrasound Guided Erector Spinae Plane Block and Combined Ultrasound Guided Pericapsular Nerve Group (PENG) and Lateral Femoral Nerve Block Following Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06402006
- Acronym / sponsor ID
- FAMSU R79/2024
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 7 May 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 patients will be randomized into 2 equal groups by a computer-generated random numbers table, named group A, B.
Group A: patients will receive Pericapsular nerve group block and lateral femoral cutaneous nerve blocks.
Group B: Patients will receive Erector spinae plane block.
After IV access insertion and oxygen nasal cannula application, monitoring will be applied for all patients, sedation in the form of midazolam 0.02mg/kg with or without fentanyl 0.5-1 mcg/kg will be administered to any of the patients who felt discomfort or could not tolerate the procedure.
For (Group A) PENG block will be done before spinal anesthesia.
LFCN block will be performed.
For (Group B), ESP block will be done before spinal anesthesia.
Spinal anesthesia will be chosen as the main anesthetic technique.
In postoperative period all patients will receive the same adjuvant multimodal analgesia which will be 1000 mg of paracetamol with or without 30 mg ketorolac depending on comorbidities and depending on the patients" needs.
Detailed description
The patients will be randomized into 2 equal groups by a computer-generated random numbers table, named group A, B.
Group A: patients will receive PENG and LFCN blocks.
Group B: Patients will receive ESP block, which will be the control group.
After obtaining approval from Ain Shams hospital academic and ethical committee, written, informed and valid consent will be taken from all participants after proper explanation of the study procedure and the expected outcome in a clear language for patients of either sex, aging from 18 to 65 years old, ASA physical status (I, II) scheduled for total hip arthroplasty surgeries.
Patients with the following criteria will be excluded from the study: Patient refusal, ASA physical status III or more, known allergy to any of the study drugs, infection at the site of injection, history of cardiovascular, renal, hepatic or neuromuscular diseases, history of any psychiatric disorder, presence of any coagulopathy, chronic opioid, gabapentin or pregabalin use, BMI more than 35 kg/m2. Patients will be randomly assigned to either both PENG and LFCN blocks and ESP block with ultrasound guidance before spinal anesthesia.
After IV access insertion and oxygen nasal cannula application, ECG (Electrocardiography), pulse oximeter, noninvasive blood pressure monitoring will be applied for all patients, sedation in the form of midazolam 0.02mg/kg with or without fentanyl 0.5-1 mcg/kg will be administered to any of the patients who felt discomfort or could not tolerate the procedure.
For (Group A) PENG block will be done before spinal anesthesia ultrasound-guided using a curvilinear array ultrasound transducer (2-5 MHz) Sono site M-turbo ultrasonography. While the patient is in the supine position, the probe will be placed in parallel to the inguinal crease and will be rotated clockwise until visualizing femoral artery, iliopsoas muscle tendon, anterior inferior iliac spine (AIIS) and ilio-pubic eminence. 22G 80 mm needle will be inserted in plane from lateral side of probe until tip of needle touch iliopubic eminence, after negative aspiration 20 ml of bupivacaine 0.5% will be injected. Success of injection will be confirmed by fluid spreading between the iliopsoas tendon and periosteum of iliopubic eminence.
LFCN block will be performed using linear ultrasound probe (10-15 MHz). while the patient is in supine position the probe will be directed caudally to AIIS until visualizing LFCN between sartorius muscle and tensor fascia latae. 5 ml of bupivacaine will be injected after negative aspiration.
For (Group B), ESP block will be done before spinal anesthesia in the lateral decubitus position by curvilinear probe (2-5 MHz). Probe will be placed on the third lumber vertebra in the parasagittal line to identify the transverse process of L3. Needle will be directed in plane caudo-cephalic to the lateral edge of L3 transverse process. 30 ml of bupivacaine will be injected under visualization along the erector spinae plane. Correct placement will be defined by spread of local anesthetic cranially and caudally from injection point, dissecting the plane between the transverse processes and erector spinae muscles.
Spinal anesthesia will be chosen as the main anesthetic technique by injecting 3-3.5 ml of hyperbaric bupivacaine 0.5% by 24 G pencil-point needle at L2-L3 or L3-L4 space with 25 ug of fentanyl as adjuvant while patient is in setting position.
In postoperative period all patients will receive the same adjuvant multimodal analgesia which will be 1000 mg of paracetamol with or without 30 mg ketorolac depending on comorbidities and depending on the patients" needs.
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 |
|---|---|---|
| Combined hip joint PENG block and LFCN block | Experimental | Procedure: PENG block, Procedure: LFCN blockCombined hip joint pericapsular nerve group block(PENG) and lateral femoral cutaneous nerve block |
| ESP block | Experimental | Procedure: ESP blockErector spinae plane block(ESP) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients American Society of anesthesiologists' physical status (ASA) I to III.
- Aged 18 to 65 years.
- Both sexes.
- Patients scheduled for total hip arthroplasty.
Key exclusion criteria (12 listed)
- Patient refusal
- ASA physical status III or more.
- Patients with known allergy to any of the study drugs.
- Infection at the site of injection.
- Patients with history of cardiovascular disease.
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 blockpericapsular nerve group block | Procedure or surgery | Combined hip joint PENG block and LFCN block |
| LFCN blockLateral femoral cutaneous nerve block | Procedure or surgery | Combined hip joint PENG block and LFCN block |
| ESP blockErector spinae plane block | Procedure or surgery | ESP block |
Primary outcome
individual visual analog pain scores at 0, 6, 12, 24 and 48 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).
Time frame: 48 hours
The primary outcomes include : individual visual analog pain scores at 0, 6, 12, 24 and 48 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).
presence of moderate-to-severe pain, defined as pain score 4 or greater during the first 48 h postoperative.
Time frame: 48 hours
presence of moderate-to-severe pain, defined as pain score 4 or greater during the first 48 h postoperative.
analgesic consumption in post-anesthesia care unit, and during the first 48 h post-surgery (converted to IV pethidine equivalents).
Time frame: 48 hours
analgesic consumption in post-anesthesia care unit, and during the first 48 h post-surgery (converted to IV pethidine equivalents).
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 4 May 2025.
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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 block, LFCN block and ESP block in people with 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 12 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 4 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?
individual visual analog pain scores at 0, 6, 12, 24 and 48 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable). (time frame: 48 hours). The study lists 3 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 4 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.