Hip FracturesNCT05660603
Circum-Psoas Blocks Versus Combined Lumbar and Sacral Plexus Blocks in Hip Fracture Surgery
A study testing LSP, CP and Ultrasound in people with Hip Fractures, run by Zagazig University at 1 site in Egypt.
Trial summary
Hip fracture (HF) is one of the major worldwide problems that constitute a significant mortality rate, ranging from 14- 36% in the first year after injury, and is associated with profound temporary and sometimes permanent impairment of independence and quality of life in the geriatric population. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- LSP, CP and Ultrasound
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2022to 1 Apr 2026
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient acceptance.
- BMI ≤ 30 kg/m2
- ASA I-III.
- First unilateral surgery for hip fracture including femoral neck, intertrochanteric or subtrochanteric fracture.
- Patient with planned hip fracture surgery within 24-72 hours under general anesthesia.
Who cannot join
- Multiple trauma, multiple fractures, or pathological fractures
- Prosthetic fracture or usage of bone-cement fixation in the surgery.
- Scheduled for bilateral hip fracture surgery.
- Pre-existing neurological deficit in the lower extremity
- Contraindication for peripheral nerve block (infection at the site of needle insertion, coagulopathy, allergy to local anesthetics used)
- History of chronic pain and taking analgesics
- History of cognitive dysfunction or mental illness
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
Shereen E Abd Ellatif
Zagazig, Alsharqia, 4115
Shereen E Abd Ellatif, MD, 01007948840 ext. 002, shosh.again@gmail.com
Shereen E Abd Ellatif, MD
About this study
Official title: Circum-Psoas Blocks Versus Combined Lumbar and Sacral Plexus Blocks for Sensory Level and Postoperative Analgesia Obtained in Hip Fracture Surgery
Hip fracture (HF) is one of the major worldwide problems that constitute a significant mortality rate, ranging from 14- 36% in the first year after injury, and is associated with profound temporary and sometimes permanent impairment of independence and quality of life in the geriatric population. Surgical treatment is considered the best option for patients with hip fractures,s especially in the elderly, however, it is associated with moderate to severe postoperative pain.
Pain is one of the main factors limiting ambulation, increasing the risk of thromboembolism by immobility and causing metabolic changes that affect other systems. Therefore, individualized pain management with the use of appropriate analgesic techniques is of paramount importance. Moreover, early intervention of rehabilitation aiming at a better postoperative recovery may reduce the length of hospital stay and return to daily. Effective pain management is one of the crucial components in enhanced recovery after surgery (ERAS).
Read more
- Numerous regional anesthetic techniques have been used to provide analgesia following hip fracture surgery, including intrathecal morphine, epidural analgesia, fascia iliaca block, lumber plexus block, and sacral plexus block, however, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for hip fracture surgery.
To our knowledge, there is no study done to compare circum-psoas block versus the combined lumbar and sacral plexus blocks as pre-emptive analgesia in patients undergoing hip fracture surgery under general anesthesia.
Read the detailed description
The acetabulum and the head of the femur combine to produce a traditional ball and socket joint in the hip. Both the lumbar (L1-L4) and sacral (L4-S4) plexuses innervate the hip joint, and its sensory innervation is from the femoral (FN), obturator, and sciatic nerves with contribution from superior gluteal nerve and nerve to quadratus femoris. Cutaneous innervation is by lateral femoral cutaneous (LFCN), subcostal iliohypogastric nerve, and the superior cluneal nerves which predominately arise from the dorsal rami of L1.
Hip fracture is a major worldwide public health problem in elderly patients aged 65 years and over with an incidence of more than 1.6 million worldwide each year. Furthermore, the total number is expected to exceed 6 million by 2050. Generally, early surgical repair within 48-72 hours after admission is recommended according to the treatment guideline, however, elderly patients with hip fractures commonly have several comorbidities, which make these patients more liable to a high risk of morbidity and mortality after surgery. Pain, both before and during the first 24 hours of surgery is usually reported as severe by most patients therefore, one of the keys to a patient's recovery following hip fracture surgery, is effective postoperative pain management. Recently, the concept of pain relief with multimodal analgesia and regional anesthesia plays a vital role in postoperative analgesia minimizing opioid consumption and reducing the time to early mobilization. The acetabulum and the head of the femur combine to produce a traditional ball and socket joint in the hip. The lumbar (L1-L4) and sacral (L4-S4) plexuses both innervate the hip joint, and its sensory innervation is from the femoral (FN), obturator, and sciatic nerves with contribution from superior gluteal nerve and nerve to quadratus femoris. Cutaneous innervation is by lateral femoral cutaneous (LFCN), subcostal iliohypogastric nerve, and the superior cluneal nerves which predominately arise from the dorsal rami of L1.
Hip fracture is a major worldwide public health problem in elderly patients aged 65 years and over with an incidence of more than 1.6 million worldwide each year. Furthermore, the total number is expected to exceed 6 million by 2050. Generally, early surgical repair within 48-72 hours after admission is recommended according to the treatment guideline, however, elderly patients with hip fractures commonly have several comorbidities, which make these patients more liable to a high risk of morbidity and mortality after surgery. Pain, both before and during the first 24 hours of surgery is usually reported as severe by most patients therefore, one of the keys to a patient's recovery following hip fracture surgery, is effective postoperative pain management. Recently, the concept of pain relief with multimodal analgesia and regional anesthesia plays a vital role in postoperative analgesia minimizing opioid consumption and reducing the time to early mobilization. Several regional anesthetic techniques have been recommended, including intrathecal morphine, patient-controlled epidural analgesia, and various peripheral nerve blocks techniques; however, to obtain complete sensory loss for hip fracture surgery, it's required to block the branches of both lumbar and sacral plexuses, although there remains no single technique that reliably acquires this. Moreover, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for hip fracture surgery.
The ultrasound-guided lumbar plexus block results in the blockade of the FN, LFCN, and obturator nerve while the sacral plexus block results in the blockade of the sciatic nerve, superior and inferior gluteal nerves, posterior cutaneous nerve of the thigh, and the inferior hypogastric plexus. Thus, the combination of lumbar plexus and sacral plexus blocks results in complete analgesia of the ipsilateral lower limb in the perioperative period.
Circum-psoas blocks is a new sonar-guided fascial block technique proposed by Huili et al., where the two main branches of the lumbar plexus (FN and LFCN) can be blocked by local anesthetic (LA) injection posterior to transversalis fascia (TF) and around the anterolateral edge of psoas muscle (PM) just cranial to iliac crest. Furthermore, cranial spread along TF may lead to a lower thoracic paravertebral block through the medial arcuate ligament. On the other hand, the obturator nerve and lumbosacral trunk could be blocked if the LA is injected at the level of L5/S1 into the retro-psoas space and around the posterior edge of PM.
Our study will be designed to evaluate and compare the impact of combined lumbar and sacral plexus blocks and circum-psoas blocks for sensory level and achievement of postoperative analgesia for patients undergoing hip fracture surgery under general anesthesia.
- Conditions
- Hip Fractures
- Being tested
- control, LSP, CP, Ultrasound
- Keywords
- circum-psoas blocks, lumbar plexus block, sacral plexus block, hip fracture surgery
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlOther
patients will receive standard general anesthesia
LSPProcedure or surgery
patients will receive standard general anesthesia followed by ultrasound-guided combined lumbar and sacral plexus blocks with 40 ml of bupivacaine 0.25%.
CPProcedure or surgery
patients will receive standard general anesthesia followed by ultrasound-guided circum-psoas blocks with 40 ml of bupivacaine 0.25%.
UltrasoundDevice
ultrasound
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | patients will be operated on under general anesthesia Receives: Other: control |
| LSP group (lumbar and sacral plexus block) | Active comparator | patients will receive ultrasound-guided combined lumbar and sacral plexus blocks with 40 ml of 0.25% of bupivacaine. Receives: Procedure: LSP; Device: Ultrasound |
| CP group (circum-psoas block) | Active comparator | patients will receive ultrasound-guided circum-psoas blocks with 40 ml of 0.25% of bupivacaine. Receives: Procedure: CP; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess change of Visual analogue scale (VAS)
On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain
Measured: at 30 minutes, 2 hours, 4, 6,12, 24 hours postoperatively
Secondary outcomes (2)
Assess sensory block levels
by using alteration of pinprick sensation compared to the contralateral side on the dermatomes supplied by blocked nerves
Measured: at 2 hours postoperatively
Total dose of rescue analgesia
once the VAS score will be ≥ 3, rescue analgesia in the form of 1 μg/kg fentanyl will be given and the total dose consumed will be recorded
Measured: in the first 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start20 Dec 2022
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be divided randomly by a computer-generated randomization table into three groups : Group C :(Control group) patients will receive standard general anesthesia. Group LSP: patients will receive standard general anesthesia followed by combined lumbar and sacral plexus blocks with 40 ml of bupivacaine 0.25%. Group CP: patients will receive standard general anesthesia followed by circum-psoas block with 40 ml of bupivacaine 0.25%.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shereen Elsayed Abd Ellatif, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660603
- Sponsor's protocol ID
- 10177/13/12/2022
- Status last verified
- Jul 2025
- First submitted
- 13 Dec 2022
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: planned after the completion of the study and publication
Publications
Roche JJ, Wenn RT, Sahota O, Moran CG. Effect of comorbidities and postoperative complications on mortality after hip fracture in elderly people: prospective observational cohort study. BMJ. 2005 Dec 10;331(7529):1374. doi: 10.1136/bmj.38643.663843.55. Epub 2005 Nov 18.
PubMed 16299013Bendtsen TF, Pedersen EM, Haroutounian S, Soballe K, Moriggl B, Nikolajsen L, Hasselstrom JB, Fisker AK, Strid JM, Iversen B, Borglum J. The suprasacral parallel shift vs lumbar plexus blockade with ultrasound guidance in healthy volunteers--a randomised controlled trial. Anaesthesia. 2014 Nov;69(11):1227-40. doi: 10.1111/anae.12753. Epub 2014 Jun 28.
PubMed 24974961Petchara S, Paphon S, Vanlapa A, Boontikar P, Disya K. Combined Lumbar-Sacral Plexus Block in High Surgical Risk Geriatric Patients undergoing Early Hip Fracture Surgery. Malays Orthop J. 2015 Nov;9(3):28-34. doi: 10.5704/MOJ.1511.004.
PubMed 28611906Li H, Shi R, Shao P, Wang Y. Evaluation of Sensory Loss Obtained by Circum-Psoas Blocks in Patients Undergoing Total Hip Replacement: A Descriptive Pilot Study. J Pain Res. 2022 Mar 29;15:827-835. doi: 10.2147/JPR.S354829. eCollection 2022.
PubMed 35378731
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circum-Psoas Blocks Versus Combined Lumbar and Sacral Plexus Blocks for Sensory Level and Postoperative Analgesia Obtained in Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT05660603
- Acronym / sponsor ID
- 10177/13/12/2022
- Conditions
- Hip Fractures
- Keywords
- circum-psoas blocks, lumbar plexus block, sacral plexus block, hip fracture surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 21 Dec 2022 (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.
Hip fracture (HF) is one of the major worldwide problems that constitute a significant mortality rate, ranging from 14- 36% in the first year after injury, and is associated with profound temporary and sometimes permanent impairment of independence and quality of life in the geriatric population. Surgical treatment is considered the best option for patients with hip fractures,s especially in the elderly, however, it is associated with moderate to severe postoperative pain.
Pain is one of the main factors limiting ambulation, increasing the risk of thromboembolism by immobility and causing metabolic changes that affect other systems. Therefore, individualized pain management with the use of appropriate analgesic techniques is of paramount importance. Moreover, early intervention of rehabilitation aiming at a better postoperative recovery may reduce the length of hospital stay and return to daily. Effective pain management is one of the crucial components in enhanced recovery after surgery (ERAS).
- Numerous regional anesthetic techniques have been used to provide analgesia following hip fracture surgery, including intrathecal morphine, epidural analgesia, fascia iliaca block, lumber plexus block, and sacral plexus block, however, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for hip fracture surgery.
To our knowledge, there is no study done to compare circum-psoas block versus the combined lumbar and sacral plexus blocks as pre-emptive analgesia in patients undergoing hip fracture surgery under general anesthesia.
Detailed description
The acetabulum and the head of the femur combine to produce a traditional ball and socket joint in the hip. Both the lumbar (L1-L4) and sacral (L4-S4) plexuses innervate the hip joint, and its sensory innervation is from the femoral (FN), obturator, and sciatic nerves with contribution from superior gluteal nerve and nerve to quadratus femoris. Cutaneous innervation is by lateral femoral cutaneous (LFCN), subcostal iliohypogastric nerve, and the superior cluneal nerves which predominately arise from the dorsal rami of L1.
Hip fracture is a major worldwide public health problem in elderly patients aged 65 years and over with an incidence of more than 1.6 million worldwide each year. Furthermore, the total number is expected to exceed 6 million by 2050. Generally, early surgical repair within 48-72 hours after admission is recommended according to the treatment guideline, however, elderly patients with hip fractures commonly have several comorbidities, which make these patients more liable to a high risk of morbidity and mortality after surgery. Pain, both before and during the first 24 hours of surgery is usually reported as severe by most patients therefore, one of the keys to a patient's recovery following hip fracture surgery, is effective postoperative pain management. Recently, the concept of pain relief with multimodal analgesia and regional anesthesia plays a vital role in postoperative analgesia minimizing opioid consumption and reducing the time to early mobilization. The acetabulum and the head of the femur combine to produce a traditional ball and socket joint in the hip. The lumbar (L1-L4) and sacral (L4-S4) plexuses both innervate the hip joint, and its sensory innervation is from the femoral (FN), obturator, and sciatic nerves with contribution from superior gluteal nerve and nerve to quadratus femoris. Cutaneous innervation is by lateral femoral cutaneous (LFCN), subcostal iliohypogastric nerve, and the superior cluneal nerves which predominately arise from the dorsal rami of L1.
Hip fracture is a major worldwide public health problem in elderly patients aged 65 years and over with an incidence of more than 1.6 million worldwide each year. Furthermore, the total number is expected to exceed 6 million by 2050. Generally, early surgical repair within 48-72 hours after admission is recommended according to the treatment guideline, however, elderly patients with hip fractures commonly have several comorbidities, which make these patients more liable to a high risk of morbidity and mortality after surgery. Pain, both before and during the first 24 hours of surgery is usually reported as severe by most patients therefore, one of the keys to a patient's recovery following hip fracture surgery, is effective postoperative pain management. Recently, the concept of pain relief with multimodal analgesia and regional anesthesia plays a vital role in postoperative analgesia minimizing opioid consumption and reducing the time to early mobilization. Several regional anesthetic techniques have been recommended, including intrathecal morphine, patient-controlled epidural analgesia, and various peripheral nerve blocks techniques; however, to obtain complete sensory loss for hip fracture surgery, it's required to block the branches of both lumbar and sacral plexuses, although there remains no single technique that reliably acquires this. Moreover, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for hip fracture surgery.
The ultrasound-guided lumbar plexus block results in the blockade of the FN, LFCN, and obturator nerve while the sacral plexus block results in the blockade of the sciatic nerve, superior and inferior gluteal nerves, posterior cutaneous nerve of the thigh, and the inferior hypogastric plexus. Thus, the combination of lumbar plexus and sacral plexus blocks results in complete analgesia of the ipsilateral lower limb in the perioperative period.
Circum-psoas blocks is a new sonar-guided fascial block technique proposed by Huili et al., where the two main branches of the lumbar plexus (FN and LFCN) can be blocked by local anesthetic (LA) injection posterior to transversalis fascia (TF) and around the anterolateral edge of psoas muscle (PM) just cranial to iliac crest. Furthermore, cranial spread along TF may lead to a lower thoracic paravertebral block through the medial arcuate ligament. On the other hand, the obturator nerve and lumbosacral trunk could be blocked if the LA is injected at the level of L5/S1 into the retro-psoas space and around the posterior edge of PM.
Our study will be designed to evaluate and compare the impact of combined lumbar and sacral plexus blocks and circum-psoas blocks for sensory level and achievement of postoperative analgesia for patients undergoing hip fracture surgery under general anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The patients will be divided randomly by a computer-generated randomization table into three groups : Group C :(Control group) patients will receive standard general anesthesia. Group LSP: patients will receive standard general anesthesia followed by combined lumbar and sacral plexus blocks with 40 ml of bupivacaine 0.25%. Group CP: patients will receive standard general anesthesia followed by circum-psoas block with 40 ml of bupivacaine 0.25%.
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Other: controlpatients will be operated on under general anesthesia |
| LSP group (lumbar and sacral plexus block) | Active comparator | Procedure: LSP, Device: Ultrasoundpatients will receive ultrasound-guided combined lumbar and sacral plexus blocks with 40 ml of 0.25% of bupivacaine. |
| CP group (circum-psoas block) | Active comparator | Procedure: CP, Device: Ultrasoundpatients will receive ultrasound-guided circum-psoas blocks with 40 ml of 0.25% of bupivacaine. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient acceptance.
- BMI ≤ 30 kg/m2
- ASA I-III.
- First unilateral surgery for hip fracture including femoral neck, intertrochanteric or subtrochanteric fracture.
- Patient with planned hip fracture surgery within 24-72 hours under general anesthesia.
Key exclusion criteria (7 listed)
- Multiple trauma, multiple fractures, or pathological fractures
- Prosthetic fracture or usage of bone-cement fixation in the surgery.
- Scheduled for bilateral hip fracture surgery.
- Pre-existing neurological deficit in the lower extremity
- Contraindication for peripheral nerve block (infection at the site of needle insertion, coagulopathy, allergy to local anesthetics used)
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 |
|---|---|---|
| controlpatients will receive standard general anesthesia | Other | control group |
| LSPpatients will receive standard general anesthesia followed by ultrasound-guided combined lumbar and sacral plexus blocks with 40 ml of bupivacaine 0.25%. | Procedure or surgery | LSP group (lumbar and sacral plexus block) |
| CPpatients will receive standard general anesthesia followed by ultrasound-guided circum-psoas blocks with 40 ml of bupivacaine 0.25%. | Procedure or surgery | CP group (circum-psoas block) |
| Ultrasoundultrasound | Device | CP group (circum-psoas block), LSP group (lumbar and sacral plexus block) |
Primary outcome
Assess change of Visual analogue scale (VAS)
Time frame: at 30 minutes, 2 hours, 4, 6,12, 24 hours postoperatively
On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain
2 secondary outcomes
Assess sensory block levels
Time frame: at 2 hours postoperatively
Total dose of rescue analgesia
Time frame: in the first 24 hour postoperatively
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 17 Jul 2025.
- Background: PubMed 16299013Roche JJ, Wenn RT, Sahota O, Moran CG. Effect of comorbidities and postoperative complications on mortality after hip fracture in elderly people: prospective observational cohort study. BMJ. 2005 Dec 10;331(7529):1374. doi: 10.1136/bmj.38643.663843.55. Epub 2005 Nov 18.
- Background: PubMed 24974961Bendtsen TF, Pedersen EM, Haroutounian S, Soballe K, Moriggl B, Nikolajsen L, Hasselstrom JB, Fisker AK, Strid JM, Iversen B, Borglum J. The suprasacral parallel shift vs lumbar plexus blockade with ultrasound guidance in healthy volunteers--a randomised controlled trial. Anaesthesia. 2014 Nov;69(11):1227-40. doi: 10.1111/anae.12753. Epub 2014 Jun 28.
- Background: PubMed 28611906Petchara S, Paphon S, Vanlapa A, Boontikar P, Disya K. Combined Lumbar-Sacral Plexus Block in High Surgical Risk Geriatric Patients undergoing Early Hip Fracture Surgery. Malays Orthop J. 2015 Nov;9(3):28-34. doi: 10.5704/MOJ.1511.004.
- Background: PubMed 35378731Li H, Shi R, Shao P, Wang Y. Evaluation of Sensory Loss Obtained by Circum-Psoas Blocks in Patients Undergoing Total Hip Replacement: A Descriptive Pilot Study. J Pain Res. 2022 Mar 29;15:827-835. doi: 10.2147/JPR.S354829. eCollection 2022.
- Individual participant dataSharing planned: Yes. planned after the completion of the study and publication
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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 study testing LSP, CP and Ultrasound in people with Hip Fractures, run by Zagazig 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 5 inclusion and 7 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 17 Jul 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. Some participants in this study may receive a placebo. 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?
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 Shereen E Abd Ellatif, MD (01007948840 ext. 002, shosh.again@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess change of Visual analogue scale (VAS) (time frame: at 30 minutes, 2 hours, 4, 6,12, 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05660603, which also lists 4 linked publications.
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 17 Jul 2025.