Pain ManagementPhase 3NCT07467356
Anterior Iliopsoas Space Block Versus PENG Block on Ease of Positioning for Spinal Anathesia in Patients Undergoing Hip Surgeries
A Phase 3 study testing Bupivacaine in people with Pain Management, run by Benha University at 1 site in Egypt.
Trial summary
Total hip arthroplasty (THA) has been one of the most significant advancements in orthopedic surgery over the past century. hip fractures are typically associated with severe pain, effective analgesia is crucial both before and after surgery.Spinal anesthesia (SA) is the most commonly employed method of anesthesia for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management
- What is being tested?
- Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2026to 15 Nov 2026
- Phase
- Phase 3
- 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
- (ASA )classes I and II
- patients of either sex, above the age of 18 who will undergo hip surgeries( (Dynamic hip screw fixation or hemiarthroplasty)(not older than 2 weeks) with persistent pain and scheduled for surgery under SA with an expected duration of 2.5 hours
Who cannot join
- patient's refusal to participate
- any contraindications to SA or peripheral nerve blocks
- history of ischemic heart disease
- patients on opioids for chronic pain
- patients with significant cognitive impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Banha Faculity of Medicine
Banhā, Elqalyoubea, 13511
fatma ahmed abdelfataah, MD, 00201091921540, drfatmaahmed86@gmail.com
About this study
Official title: Impact of Anterior Iliopsoas Space Block Versus PENG Block on Ease of Positioning for Spinal Anathesia in Patients Undergoing Hip Surgeries ;Randomized Clinical Trial
Total hip arthroplasty (THA) has been one of the most significant advancements in orthopedic surgery over the past century. hip fractures are typically associated with severe pain, effective analgesia is crucial both before and after surgery.Spinal anesthesia (SA) is the most commonly employed method of anesthesia for repairing these fractures.The anterior iliopsoas space block is a considered as a novel technique that targets the lumbosacral trunk as it passes beneath the psoas major muscle, offering potential advantages over the traditional sacral plexus block, which is performed in the supine position.
Read the detailed description
Total hip arthroplasty (THA) has been one of the most significant advancements in orthopedic surgery over the past century. hip fractures are typically associated with severe pain, effective analgesia is crucial both before and after surgery.
Consequently, efforts are made to facilitate enhanced recovery profiles to reduce postoperative pain in THA patients. At present, multimodal analgesia approaches have been used for pain management after THA, including oral analgesia, epidural analgesia, and peripheral nerve block.
Spinal anesthesia (SA) is the most commonly employed method of anesthesia for repairing these fractures. The intense pain resulting from the fracture can impede the optimal positioning required for these procedures , rendering access to the subarachnoid space challenging. Suboptimal postoperative analgesia may restrict limb mobility, consequently delaying recovery and increasing opioid consumption. Therefore, it is imperative to establish effective perioperative analgesia strategies that not only reduce the reliance on opioids but also mitigate their adverse effects, particularly in this patient population .
Based on previous anatomical studies, it has been established that the articular branches of the femoral nerve, the obturator nerve, and the accessory obturator nerve (AON) play a crucial role in innervating the anterior hip capsule. Consequently, these nerves are identified as the primary targets for hip analgesia, and their effective blockade can be achieved through the peri-capsular nerve group (PENG) technique .
Recently, The anterior iliopsoas space block is a considered as a novel technique that targets the lumbosacral trunk as it passes beneath the psoas major muscle, offering potential advantages over the traditional sacral plexus block, which is performed in the supine position.
- Conditions
- Pain Management
- Being tested
- Bupivacaine
- Keywords
- PENG block, anterior iliopsoas space block, ease of positioning, hip surgeries
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
The site to be blocked will be painted with 5% povidone iodine followed by 70% ethyl alcohol and draped. Linear high-frequency ultrasound probe (7 -15 mhz) (General Electric; GE, "LOGIQ E") will be initially placed in a transverse plane over the anterior superior iliac spine (ASIS) and then alignes to identify the following landmarks: Anterior inferior iliac spine, ilio-pubic eminence, iliopsoas muscle and tendon, the femoral artery, and Pectineus muscle. Point of injection will be musculo-fascial plane between the psoas tendon and ilio-pubic eminence.
BupivacaineDrug
placing a patient supine, identifying the anterior superior iliac spine and iliac crest, the skin of the block region will be cleaned with 5% povidone iodine followed by 70% ethyl alcohol .Both the sterile window sheets and probe will be covered with sterile drapes. A standardised amount of local anaesthetic will be administered utilising ultrasound guidance and a portable ultrasound system (General Electric; GE, "LOGIQ P5")to visualize the iliopsoas muscle in a transverse or longitudinal scan. The needle is advanced in-plane to the fascial plane between the iliopsoas muscle and the iliofemoral ligament or iliac bone, and local anesthetic is injected to spread along the iliopsoas muscle.
| Study group | Role | What they receive |
|---|---|---|
| Group (P) | Active comparator | patients will receive PENG block(using bupivacaine 0.20% 25ml). Receives: Drug: Bupivacaine |
| Group (A) | Active comparator | patients will receive anterior ilio-psoas space block(using bupivacaine 0.20% 25ml). Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the ease of spinal positioning
EOSP will be 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 without pain)
Measured: 30 minutes after block
Secondary outcomes (3)
VAS at rest and on passive 15° limb lifting
0 no pain and 10 the strongest pain imaginable
Measured: 30 minutes after block 2 hours postoperatively 6 hours postoperatively 12 hours postoperatively 24 hours postoperatively
amount of pethidine intake
amount of pethidine taken by the patient after surgery to relieve pain
Measured: 24 hours postoperatively
quality of recovery score
This questionnaire covers a total of 15 questions under five clinical dimensions of health; physical comfort (five-item), emotional status (four-item), psychological support (two-item), physical independence (two-item) and pain (two-item). a numerical rating scale of 11 point for each question leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start15 Mar 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Ahmed Abdel Fatah, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467356
- Sponsor's protocol ID
- RC 18-2-2026
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anterior Iliopsoas Space Block Versus PENG Block on Ease of Positioning for Spinal Anathesia in Patients Undergoing Hip Surgeries ;Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07467356
- Acronym / sponsor ID
- RC 18-2-2026
- Conditions
- Pain Management
- Keywords
- PENG block, anterior iliopsoas space block, ease of positioning, hip surgeries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 12 Mar 2026 (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.
Total hip arthroplasty (THA) has been one of the most significant advancements in orthopedic surgery over the past century. hip fractures are typically associated with severe pain, effective analgesia is crucial both before and after surgery.Spinal anesthesia (SA) is the most commonly employed method of anesthesia for repairing these fractures.The anterior iliopsoas space block is a considered as a novel technique that targets the lumbosacral trunk as it passes beneath the psoas major muscle, offering potential advantages over the traditional sacral plexus block, which is performed in the supine position.
Detailed description
Total hip arthroplasty (THA) has been one of the most significant advancements in orthopedic surgery over the past century. hip fractures are typically associated with severe pain, effective analgesia is crucial both before and after surgery.
Consequently, efforts are made to facilitate enhanced recovery profiles to reduce postoperative pain in THA patients. At present, multimodal analgesia approaches have been used for pain management after THA, including oral analgesia, epidural analgesia, and peripheral nerve block.
Spinal anesthesia (SA) is the most commonly employed method of anesthesia for repairing these fractures. The intense pain resulting from the fracture can impede the optimal positioning required for these procedures , rendering access to the subarachnoid space challenging. Suboptimal postoperative analgesia may restrict limb mobility, consequently delaying recovery and increasing opioid consumption. Therefore, it is imperative to establish effective perioperative analgesia strategies that not only reduce the reliance on opioids but also mitigate their adverse effects, particularly in this patient population .
Based on previous anatomical studies, it has been established that the articular branches of the femoral nerve, the obturator nerve, and the accessory obturator nerve (AON) play a crucial role in innervating the anterior hip capsule. Consequently, these nerves are identified as the primary targets for hip analgesia, and their effective blockade can be achieved through the peri-capsular nerve group (PENG) technique .
Recently, The anterior iliopsoas space block is a considered as a novel technique that targets the lumbosacral trunk as it passes beneath the psoas major muscle, offering potential advantages over the traditional sacral plexus block, which is performed in the supine position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (P) | Active comparator | Drug: Bupivacainepatients will receive PENG block(using bupivacaine 0.20% 25ml). |
| Group (A) | Active comparator | Drug: Bupivacainepatients will receive anterior ilio-psoas space block(using bupivacaine 0.20% 25ml). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (ASA )classes I and II
- patients of either sex, above the age of 18 who will undergo hip surgeries( (Dynamic hip screw fixation or hemiarthroplasty)(not older than 2 weeks) with persistent pain and scheduled for surgery under SA with an expected duration of 2.5 hours
Key exclusion criteria (5 listed)
- patient's refusal to participate
- any contraindications to SA or peripheral nerve blocks
- history of ischemic heart disease
- patients on opioids for chronic pain
- patients with significant cognitive impairment.
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 |
|---|---|---|
| BupivacaineThe site to be blocked will be painted with 5% povidone iodine followed by 70% ethyl alcohol and draped. Linear high-frequency ultrasound probe (7 -15 mhz) (General Electric; GE, "LOGIQ E") will be initially placed in a transverse plane over the anterior superior iliac spine (ASIS) and then alignes to identify the following landmarks: Anterior inferior iliac spine, ilio-pubic eminence, iliopsoas muscle and tendon, the femoral artery, and Pectineus muscle. Point of injection will be musculo-fascial plane between the psoas tendon and ilio-pubic eminence. | Drug | Group (P) |
| Bupivacaineplacing a patient supine, identifying the anterior superior iliac spine and iliac crest, the skin of the block region will be cleaned with 5% povidone iodine followed by 70% ethyl alcohol .Both the sterile window sheets and probe will be covered with sterile drapes. A standardised amount of local anaesthetic will be administered utilising ultrasound guidance and a portable ultrasound system (General Electric; GE, "LOGIQ P5")to visualize the iliopsoas muscle in a transverse or longitudinal scan. The needle is advanced in-plane to the fascial plane between the iliopsoas muscle and the iliofemoral ligament or iliac bone, and local anesthetic is injected to spread along the iliopsoas muscle. | Drug | Group (A) |
Primary outcome
the ease of spinal positioning
Time frame: 30 minutes after block
EOSP will be 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 without pain)
3 secondary outcomes
VAS at rest and on passive 15° limb lifting
Time frame: 30 minutes after block 2 hours postoperatively 6 hours postoperatively 12 hours postoperatively 24 hours postoperatively
amount of pethidine intake
Time frame: 24 hours postoperatively
quality of recovery score
Time frame: 24 hours after surgery
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 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine in people with Pain Management, run by Benha 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 2 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: looking for participants now, as of the sponsor's last update on 16 Oct 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 fatma ahmed abdelfatah, MD (00201091921540, drfatmaahmed86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the ease of spinal positioning (time frame: 30 minutes after block). 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 16 Oct 2026.