Post Operative AnalgesiaPhase 4NCT06679764
The Ultrasound Guided Pericapsular Nerve Group and Anterior Quadratus Lumborum Blocks in Hip Replacement Surgeries
A Phase 4 study testing Anterior quadratus lumborum block technique (AQLB) and Pericapsular Nerve Group (PENG) block in people with Post Operative Analgesia, run by Cairo University at 1 site in Egypt.
Trial summary
The investigators hypothesis that PENG block will produce effective opioid sparing analgesia with enhanced motor recovery more than AQLB in elderly patients undergoing total hip replacement surgeries Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Post Operative Analgesia
- What is being tested?
- Anterior quadratus lumborum block technique (AQLB) and Pericapsular Nerve Group (PENG) block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 31 Jan 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Both genders
- Type of surgery; unilateral elective total hip replacement.
- Physical status ASA I- III
- Age ≥ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
- Traumatic fracture hip through anterolateral approach.
Who cannot join
- Patient refusal.
- Patients with known sensitivity or contraindication to drugs used in the study (local anesthetics \& opioids).
- History of psychological disorders and/or chronic pain.
- Pre- existing peripheral neuropathies
- Coagulopathy.
- Infection of the skin at the site of needle puncture area.
Show all 10Show fewer
- Active cardiac condition (unstable coronary syndromes, significant arrhythmias, severe valvular disease).
- Acute respiratory disease (active chest infection, respiratory failure).
- Advanced liver disease (increased liver enzymes >3 folds) or severe kidney disease (creatinine >2).
- long operative time more than 3 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Ultrasound Guided Pericapsular Nerve Group Block and Anterior Quadratus Lumborum Block in Elderly Patients Undergoing Total Hip Replacement Surgeries: A Randomized Controlled Clinical Trial
The investigators hypothesis that PENG block will produce effective opioid sparing analgesia with enhanced motor recovery more than AQLB in elderly patients undergoing total hip replacement surgeries
Read the detailed description
Aim of the work:
The aim of this study is to compare analgesic efficacy and motor recovery of the ultrasound guided anterior quadratus lumborum block and the pericapsular nerve group block
Statistical Analysis:
Data will be coded and entered using the statistical package SPSS version 22. Categorical data will be expressed frequency and proportion and will be compared by Chi2. Numerical data will be summarized using mean and standard deviation. Comparisons between groups for normally distributed data will be done using analysis of variance (ANOVA), while for non-normally distributed numeric variable will be done by Krauskal Wallis test. P value less than or equal to 0.05 will be considered statistically significant. All test will be two tailed
- Conditions
- Post Operative Analgesia
- Being tested
- Anterior quadratus lumborum block technique (AQLB), Pericapsular Nerve Group (PENG) block, Control Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior quadratus lumborum block technique (AQLB)Procedure or surgery
AQLB performed in the lateral position. A low-frequency convex probe for the abdomen (2-5) MHz convex probe, (Siemens ACUSON X300 Ultrasound System) was placed horizontally above the iliac crest. On ultrasound, The psoas major was located on the ventral side of the transverse process, the erector spinae was located on the dorsal side of the transverse process, and the quadratus lumborum was located on the lateral side of the transverse process.
A 38-mm 22-gauge regional block needle was advanced in-plane from posterior to anterior directing the needle tip in the fascial plane between the psoas major and the quadratus lumborum that was confirmed by injecting 1 ml saline and watchingt the fluil fting the muscle while not distending any of the two muscles (hydro-localization). Then 30mL of local anaesthetic (29ml of 0.25% bupivacaine + 1 ml of dexamethasone (4mgs) was injected with observation of local anaesthesia spread in the fascial plane.
Pericapsular Nerve Group (PENG) blockProcedure or surgery
With the patients in supine position, A low-frequency convex probe (2-5 MHz) in was placed in a transverse plane over the anterior inferior iliac spine and then it was rotated 45 degrees in counter-clockwise direction to be aligned with the pubic ramus. In this view, the ilio-pubic eminence, iliopsoas muscle tendon, femoral nerve and vessels was observed. With in-plane approach, a 38-mm 22-gauge (22-G, 50-mm) regional block needle inserted in-plane, from lateral to medial to place the needle tip underneath the iliopsoas tendon, exactly between the ilipsoas fascia anteriorly and the pubic ramus posteriorly. Following negative resistance and aspiration tests, correct location of the needle tip was confirmed by injecting 1 ml saline. Then, 30mL of local anaesthetic (29ml of 0.25% bupivacaine+ 1ml of dexamethasone (4mgs) was injected while observing for adequate fluid spread.
Control GroupDrug
Pataints received opioid analgesia with genaral anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Anterior quadratus lumborum block technique (AQLB) | Active comparator | AQLB performed in the lateral position. A low-frequency convex probe for the abdomen (2-5) MHz convex probe, (Siemens ACUSON X300 Ultrasound System) was placed horizontally above the iliac crest. On ultrasound, The psoas major was located on the ventral side of the transverse process, the erector spinae was located on the dorsal side of the transverse process, and the quadratus lumborum was located on the lateral side of the transverse process.
A 38-mm 22-gauge regional block needle was advanced in-plane from posterior to anterior directing the needle tip in the fascial plane between the psoas major and the quadratus lumborum that was confirmed by injecting 1 ml saline and watchingt the fluil fting the muscle while not distending any of the two muscles (hydro-localization). Then 30mL of local anaesthetic (29ml of 0.25% bupivacaine + 1 ml of dexamethasone (4mgs) was injected with observation of local anaesthesia spread in the fascial plane. Receives: Procedure: Anterior quadratus lumborum block technique (AQLB) |
| Pericapsular Nerve Group (PENG) block | Active comparator | With the patients in supine position, A low-frequency convex probe (2-5 MHz) in was placed in a transverse plane over the anterior inferior iliac spine and then it was rotated 45 degrees in counter-clockwise direction to be aligned with the pubic ramus. In this view, the ilio-pubic eminence, iliopsoas muscle tendon, femoral nerve and vessels was observed. With in-plane approach, a 38-mm 22-gauge (22-G, 50-mm) regional block needle inserted in-plane, from lateral to medial to place the needle tip underneath the iliopsoas tendon, exactly between the ilipsoas fascia anteriorly and the pubic ramus posteriorly. Following negative resistance and aspiration tests, correct location of the needle tip was confirmed by injecting 1 ml saline. Then, 30mL of local anaesthetic (29ml of 0.25% bupivacaine+ 1ml of dexamethasone (4mgs) was injected while observing for adequate fluid spread. Receives: Procedure: Pericapsular Nerve Group (PENG) block |
| Control Group | Active comparator | Pataints received opioid analgesia with GA Receives: Drug: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Total Amount of Morphine Consumption
Total dose of IV morphine (mg) administered as rescue analgesia during the first 24 postoperative hours. Morphine 0.05 mg/kg IV boluses were given when NRS ≥4, up to a maximum of 0.3 mg/kg/24 h. Reported as median (IQR).
Measured: Immediatly post operative for 24 hours
Secondary outcomes (8)
Numeric Pain Rating Scale at Rest Over First 24 Hours
Pain intensity at rest using 0-10 Numeric Pain Rating Scale (0 = no pain, 10 = worst imaginable pain) measured at specified time points; data reported as median (IQR).
Measured: 30 minutes, 2, 4, 6, 8, 12, 18, and 24 hours after surgery
Numeric Pain Rating Scale During Passive 90° Hip Flexion Over First 24 Hours
Pain intensity during passive 90° hip flexion using 0-10 NRS at same time points; reported as median (IQR).
Measured: at 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively
Time to First Rescue Morphine Analgesia
Time from arrival in PACU to first administration of IV morphine rescue dose (NRS ≥4). Reported as median (IQR).
Measured: Immediatly post operative for 24 hours
Manual Muscle Test (MMT) Score for Quadriceps/Iliopsoas Over First 24 Hours
Manual muscle test (0-5 scale; 0 = no contraction, 5 = full ROM against gravity and maximal resistance) for quadriceps and iliopsoas muscles on the operated side, after extubation, at predefined time points.
Measured: 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively
Active Hip Flexion Range of Motion (0°-90°) Over First 24 Hours
Active hip flexion range of motion (degrees) of the operated hip, from 0° to 90°, assessed at same time points as MMTe. Reported as median (IQR).
Measured: 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively
Total Intraoperative Fentanyl Dose
Total dose of IV fentanyl administered intraoperatively. Additional boluses of 1 μg/kg were given if MAP or HR increased by >20% above baseline. Reported as mean ± SD.
Measured: During surgery
Time to First Walk
Time from end of surgery to first ambulation (≥3 steps with walker). Reported as median (IQR)
Measured: From end of surgery until first walk (within postoperative 24 h)
Length of Hospital Stay
Time from surgery to hospital discharge. Reported as mean ± SD.
Measured: From date of surgery until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 May 2022
- Primary completion15 Sep 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Operative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Youssef, Cairo University
- Investigators
- Mohamed A Ollaek, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679764
- Sponsor's protocol ID
- MD-16-2022
- Status last verified
- Dec 2025
- First submitted
- 5 Nov 2024
- Last updated
- 30 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Ultrasound Guided Pericapsular Nerve Group Block and Anterior Quadratus Lumborum Block in Elderly Patients Undergoing Total Hip Replacement Surgeries: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06679764
- Acronym / sponsor ID
- MD-16-2022
- Conditions
- Post Operative Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 7 Nov 2024 (actual)
- Results
- Posted 30 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesis that PENG block will produce effective opioid sparing analgesia with enhanced motor recovery more than AQLB in elderly patients undergoing total hip replacement surgeries
Detailed description
Aim of the work:
The aim of this study is to compare analgesic efficacy and motor recovery of the ultrasound guided anterior quadratus lumborum block and the pericapsular nerve group block
Statistical Analysis:
Data will be coded and entered using the statistical package SPSS version 22. Categorical data will be expressed frequency and proportion and will be compared by Chi2. Numerical data will be summarized using mean and standard deviation. Comparisons between groups for normally distributed data will be done using analysis of variance (ANOVA), while for non-normally distributed numeric variable will be done by Krauskal Wallis test. P value less than or equal to 0.05 will be considered statistically significant. All test will be two tailed
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anterior quadratus lumborum block technique (AQLB) | Active comparator | Procedure: Anterior quadratus lumborum block technique (AQLB)AQLB performed in the lateral position. A low-frequency convex probe for the abdomen (2-5) MHz convex probe, (Siemens ACUSON X300 Ultrasound System) was placed horizontally above the iliac crest. On ultrasound, The psoas major was located on the ventral side of the transverse process, the erector spinae was located on the dorsal side of the transverse process, and the quadratus lumborum was located on the lateral side of the transverse process. A 38-mm 22-gauge regional block needle was advanced in-plane from posterior to anterior directing the needle tip in the fascial plane between the psoas major and the quadratus lumborum that was confirmed by injecting 1 ml saline and watchingt the fluil fting the muscle while not distending any of the two muscles (hydro-localization). Then 30mL of local anaesthetic (29ml of 0.25% bupivacaine + 1 ml of dexamethasone (4mgs) was injected with observation of local anaesthesia spread in the fascial plane. |
| Pericapsular Nerve Group (PENG) block | Active comparator | Procedure: Pericapsular Nerve Group (PENG) blockWith the patients in supine position, A low-frequency convex probe (2-5 MHz) in was placed in a transverse plane over the anterior inferior iliac spine and then it was rotated 45 degrees in counter-clockwise direction to be aligned with the pubic ramus. In this view, the ilio-pubic eminence, iliopsoas muscle tendon, femoral nerve and vessels was observed. With in-plane approach, a 38-mm 22-gauge (22-G, 50-mm) regional block needle inserted in-plane, from lateral to medial to place the needle tip underneath the iliopsoas tendon, exactly between the ilipsoas fascia anteriorly and the pubic ramus posteriorly. Following negative resistance and aspiration tests, correct location of the needle tip was confirmed by injecting 1 ml saline. Then, 30mL of local anaesthetic (29ml of 0.25% bupivacaine+ 1ml of dexamethasone (4mgs) was injected while observing for adequate fluid spread. |
| Control Group | Active comparator | Drug: Control GroupPataints received opioid analgesia with GA |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Both genders
- Type of surgery; unilateral elective total hip replacement.
- Physical status ASA I- III
- Age ≥ 65 Years.
- Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
Key exclusion criteria (10 listed)
- Patient refusal.
- Patients with known sensitivity or contraindication to drugs used in the study (local anesthetics \& opioids).
- History of psychological disorders and/or chronic pain.
- Pre- existing peripheral neuropathies
- Coagulopathy.
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 |
|---|---|---|
| Anterior quadratus lumborum block technique (AQLB)AQLB performed in the lateral position. A low-frequency convex probe for the abdomen (2-5) MHz convex probe, (Siemens ACUSON X300 Ultrasound System) was placed horizontally above the iliac crest. On ultrasound, The psoas major was located on the ventral side of the transverse process, the erector spinae was located on the dorsal side of the transverse process, and the quadratus lumborum was located on the lateral side of the transverse process. A 38-mm 22-gauge regional block needle was advanced in-plane from posterior to anterior directing the needle tip in the fascial plane between the psoas major and the quadratus lumborum that was confirmed by injecting 1 ml saline and watchingt the fluil fting the muscle while not distending any of the two muscles (hydro-localization). Then 30mL of local anaesthetic (29ml of 0.25% bupivacaine + 1 ml of dexamethasone (4mgs) was injected with observation of local anaesthesia spread in the fascial plane. | Procedure or surgery | Anterior quadratus lumborum block technique (AQLB) |
| Pericapsular Nerve Group (PENG) blockWith the patients in supine position, A low-frequency convex probe (2-5 MHz) in was placed in a transverse plane over the anterior inferior iliac spine and then it was rotated 45 degrees in counter-clockwise direction to be aligned with the pubic ramus. In this view, the ilio-pubic eminence, iliopsoas muscle tendon, femoral nerve and vessels was observed. With in-plane approach, a 38-mm 22-gauge (22-G, 50-mm) regional block needle inserted in-plane, from lateral to medial to place the needle tip underneath the iliopsoas tendon, exactly between the ilipsoas fascia anteriorly and the pubic ramus posteriorly. Following negative resistance and aspiration tests, correct location of the needle tip was confirmed by injecting 1 ml saline. Then, 30mL of local anaesthetic (29ml of 0.25% bupivacaine+ 1ml of dexamethasone (4mgs) was injected while observing for adequate fluid spread. | Procedure or surgery | Pericapsular Nerve Group (PENG) block |
| Control GroupPataints received opioid analgesia with genaral anesthesia | Drug | Control Group |
Primary outcome
The Total Amount of Morphine Consumption
Time frame: Immediatly post operative for 24 hours
Total dose of IV morphine (mg) administered as rescue analgesia during the first 24 postoperative hours. Morphine 0.05 mg/kg IV boluses were given when NRS ≥4, up to a maximum of 0.3 mg/kg/24 h. Reported as median (IQR).
8 secondary outcomes
Numeric Pain Rating Scale at Rest Over First 24 Hours
Time frame: 30 minutes, 2, 4, 6, 8, 12, 18, and 24 hours after surgery
Numeric Pain Rating Scale During Passive 90° Hip Flexion Over First 24 Hours
Time frame: at 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively
Time to First Rescue Morphine Analgesia
Time frame: Immediatly post operative for 24 hours
Manual Muscle Test (MMT) Score for Quadriceps/Iliopsoas Over First 24 Hours
Time frame: 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively
Active Hip Flexion Range of Motion (0°-90°) Over First 24 Hours
Time frame: 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively
Total Intraoperative Fentanyl Dose
Time frame: During surgery
Time to First Walk
Time frame: From end of surgery until first walk (within postoperative 24 h)
Length of Hospital Stay
Time frame: From date of surgery until discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mohamed A Ollaek, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anterior quadratus lumborum block technique (AQLB) and Pericapsular Nerve Group (PENG) block in people with Post Operative Analgesia, run by Cairo 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 6 inclusion and 10 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 30 Jan 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Total Amount of Morphine Consumption (time frame: Immediatly post operative for 24 hours). 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 30 Jan 2026.