A Phase 3 interventional study of Bupivacaine and Bupivacaine in Pain Management, sponsored by Benha University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Benha University · Phase 3, Interventional, and Treatment
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.
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.
Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.
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patients will receive PENG block(using bupivacaine 0.20% 25ml).
Drug: Bupivacaine
patients will receive anterior ilio-psoas space block(using bupivacaine 0.20% 25ml).
Drug: Bupivacaine
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.
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.
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)
Time frame: 30 minutes after block
VAS at rest and on passive 15° limb lifting
0 no pain and 10 the strongest pain imaginable
Time frame: 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
Time frame: 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).
Time frame: 24 hours after surgery
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Nov 2026, 7 months after the start.
Primary completion moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Oct 16, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Bupivacaine
Agnosia