Hip ArthropathyNCT05556759
Anterior Iliopsoas Muscle Space Block Versus Supra-iliac Anterior Quadratus Lumborum Block in Total Hip Arthroplasty
A study testing IPS and Supra-iliac QL in people with Hip Arthropathy, run by Zagazig University at 1 site in Egypt.
Trial summary
Approximately 1.66 million hip fractures happen in a year worldwide. About 95% of these fractures happen in individuals older than 60 years. Surgical treatment involving THA is considered the best option for patients with hip fractures and those with degenerative changes in the hip joint, especially in the elderly… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Hip Arthropathy
- What is being tested?
- IPS and Supra-iliac QL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2022to 1 Nov 2025
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient acceptance.
- Age 50-80 years old.
- BMI ≤ 30 kg/m2
- ASA I - III.
- Elective total hip arthroplasty under general anesthesia.
Who cannot join
- History of allergy to the LA agents used in this study
- Skin lesion at the needle insertion site,
- Those with bleeding disorders, sepsis, liver disease, and psychiatric disorders
- Pre-existing neurological deficit in the lower extremity
- 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
Faculty of medicine, zagazig university
Zagazig, Alsharqia, 4115
Shereen E Abd Ellatif, MD, 01007948840 ext. 002, shosh.again@gmail.com
About this study
Official title: Anterior Iliopsoas Muscle Space Block Versus Supra-Iliac Anterior Quadratus Lumborum Block for Analgesia in Total Hip Arthroplasty: A Randomized Controlled Trial
Approximately 1.66 million hip fractures happen in a year worldwide. About 95% of these fractures happen in individuals older than 60 years. Surgical treatment involving THA is considered the best option for patients with hip fractures and those with degenerative changes in the hip joint, 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 analgesia 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 of enhanced recovery after surgery (ERAS).
Read more
Numerous regional anesthetic techniques have been used to provide analgesia following THA, including intrathecal morphine, epidural analgesia, fascia iliaca block, lumber plexus block, sacral plexus block, and local infiltration analgesia, however, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for THA.
Up to investigators' knowledge, there is no study done to compare the supra-iliac approach to the anterior QL block versus the Anterior iliopsoas muscle space block as pre-emptive analgesia in patients undergoing THA 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. 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 the 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.
The lumbar plexus nerves, including the femoral, obturator, and lateral femoral cutaneous nerves, lie within the psoas major (PM) muscle. These nerves then exit the PM to lie within the iliopsoas compartment, between the iliacus and PM muscles. The sacral plexus is located also in the caudal extension of this anatomical space. The iliacus and psoas muscles are wrapped by the fascia iliaca. The fascia iliaca fuses superiorly with the anterior thoracolumbar fascia (transversalis fascia) that wrapped both the quadratus lumborum (QL) and the psoas muscles.
Total hip arthroplasty (THA) is a common orthopedic surgical procedure that has been successfully utilized to treat hip fractures since 1960 [4] as well, it is considered the treatment of choice for osteoarthritis of the hip joint. Both implants' types cemented and uncemented can provide good fixation, resulting in favorable long-term outcomes [5]. One of the keys to a patient's recovery following THA surgery is effective postoperative pain management. Nowadays, the concept of pain management with multimodal analgesia and regional anesthesia plays a crucial role in postoperative analgesia reducing opioids consumption and decreasing the time to mobilization. Numerous regional anesthetic techniques have been used, including patient-controlled epidural analgesia, intrathecal morphine, fascia iliaca block, lumber plexus block, sacral plexus block, and local infiltration analgesia. However, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for THA.
The ultrasound-guided (QL) block is a regional anesthetic technique that was initially proposed as an analgesic modality for abdominal surgery through many approaches: the lateral QL (QL1) block, the posterior QL (QL2) block, and the anterior QL (transmuscular) block The anterior QL block has been performed at the L3-L4 level also been used in hip surgery case reports.
A supra-iliac approach to the anterior QL block that is performed at a lower level than traditional anterior QL block approaches is considered a new approach discovered by Elsharkawy et al., and they found that a single injection between QL and Psoas muscle at the level of L5, successfully block the lumbar plexus and provide analgesia in patients undergoing total hip arthroplasty.
Anterior iliopsoas muscle space block is a new fascial block technique proposed by Dong et al., where the nerves of the lumbar plexus can be blocked by anterior injection in the iliopsoas space at the level of the anterior superior iliac spine and effectively provide perioperative analgesia for hip surgery.
This study will be designed to evaluate and compare the impact of these two fascial plane blocks for pre-emptive analgesia for patients undergoing total hip arthroplasty under general anesthesia.
- Conditions
- Hip Arthropathy
- Being tested
- control, IPS, Supra-iliac QL
- Keywords
- Anterior iliopsoas muscle space block, suprailiac anterior quadratus lumborum block, analgesia, hip arthroplasty
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlProcedure or surgery
patient will be operated under general anesthesia
IPSProcedure or surgery
Also called anterior iliopsoas muscle space block
patients will receive ultrasound-guided anterior IPS block with 30 ml of bupivacaine 0.25% followed by general anesthesia.
Supra-iliac QLProcedure or surgery
Also called supra-iliac anterior quadratus lumborum block
patients will receive ultrasound-guided supra-iliac anterior QL block with 30 ml of bupivacaine 0.25% followed by general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | patients will be operated on under general anesthesia Receives: Procedure: control |
| IPS group | Active comparator | patients will receive an ultrasound-guided anterior iliopsoas muscle space (IPS) block Receives: Procedure: IPS |
| Supra-iliac QL group | Active comparator | patients will receive an ultrasound-guided supra-iliac anterior quadratus lumborum (QL) block Receives: Procedure: Supra-iliac QL |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in Visual analogue scale (VAS)score
On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain
Measured: measured at 1 hour, 3 hours,6 hours,12hours,18hours, 24 hours postoperatively
Secondary outcomes (1)
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 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start30 Sep 2022
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hip ArthropathyStudies 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 be operated on under general anesthesia. Group IPS: patients will receive anterior IPS block with 30 ml of bupivacaine 0.25% followed by general anesthesia. Group Supra-iliac QL: patients will receive supra-iliac anterior QL block with 30 ml of bupivacaine 0.25% followed by general anesthesia.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shereen Elsayed Abd Ellatif, Zagazig University
- Investigators
- Shereen E Abd Ellatif, MD, Principal investigator, Faculty of medicine, zagazig university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556759
- Sponsor's protocol ID
- 9721-18-9-2022
- Status last verified
- Jul 2025
- First submitted
- 20 Sep 2022
- Last updated
- 15 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
Elsharkawy H, El-Boghdadly K, Barnes TJ, Drake R, Maheshwari K, Soliman LM, Horn JL, Chin KJ. The supra-iliac anterior quadratus lumborum block: a cadaveric study and case series. Can J Anaesth. 2019 Aug;66(8):894-906. doi: 10.1007/s12630-019-01312-z. Epub 2019 Mar 11.
PubMed 30953311Dong J, Zhang Y, Chen X, Ni W, Yan H, Liu Y, Shi H, Jiang W, Zhao D, Xu T. Ultrasound-guided anterior iliopsoas muscle space block versus posterior lumbar plexus block in hip surgery in the elderly: A randomised controlled trial. Eur J Anaesthesiol. 2021 Apr 1;38(4):366-373. doi: 10.1097/EJA.0000000000001452.
PubMed 33492871Chalacheewa, T, Termpornlert, S, Sa-Ngasoongsong P, Sangkum, Lisa. Regional Anesthesia for Hip Surgery Patients: Review Article. Journal of the Medical Association of Thailand 2022; 105: 152-9.
Dangle J, Kukreja P, Kalagara H. Review of Current Practices of Peripheral Nerve Blocks for Hip Fracture and Surgery. Curr Anesthesiol Rep 2020; 10:259-66.
Hockett MM, Hembrador S, Lee A. Continuous Quadratus Lumborum Block for Postoperative Pain in Total Hip Arthroplasty: A Case Report. A A Case Rep. 2016 Sep 15;7(6):129-31. doi: 10.1213/XAA.0000000000000363.
PubMed 27513972
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Iliopsoas Muscle Space Block Versus Supra-Iliac Anterior Quadratus Lumborum Block for Analgesia in Total Hip Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05556759
- Acronym / sponsor ID
- 9721-18-9-2022
- Conditions
- Hip Arthropathy
- Keywords
- Anterior iliopsoas muscle space block, suprailiac anterior quadratus lumborum block, analgesia, hip arthroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 27 Sep 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.
Approximately 1.66 million hip fractures happen in a year worldwide. About 95% of these fractures happen in individuals older than 60 years. Surgical treatment involving THA is considered the best option for patients with hip fractures and those with degenerative changes in the hip joint, 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 analgesia 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 of enhanced recovery after surgery (ERAS).
Numerous regional anesthetic techniques have been used to provide analgesia following THA, including intrathecal morphine, epidural analgesia, fascia iliaca block, lumber plexus block, sacral plexus block, and local infiltration analgesia, however, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for THA.
Up to investigators' knowledge, there is no study done to compare the supra-iliac approach to the anterior QL block versus the Anterior iliopsoas muscle space block as pre-emptive analgesia in patients undergoing THA 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. 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 the 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.
The lumbar plexus nerves, including the femoral, obturator, and lateral femoral cutaneous nerves, lie within the psoas major (PM) muscle. These nerves then exit the PM to lie within the iliopsoas compartment, between the iliacus and PM muscles. The sacral plexus is located also in the caudal extension of this anatomical space. The iliacus and psoas muscles are wrapped by the fascia iliaca. The fascia iliaca fuses superiorly with the anterior thoracolumbar fascia (transversalis fascia) that wrapped both the quadratus lumborum (QL) and the psoas muscles.
Total hip arthroplasty (THA) is a common orthopedic surgical procedure that has been successfully utilized to treat hip fractures since 1960 [4] as well, it is considered the treatment of choice for osteoarthritis of the hip joint. Both implants' types cemented and uncemented can provide good fixation, resulting in favorable long-term outcomes [5]. One of the keys to a patient's recovery following THA surgery is effective postoperative pain management. Nowadays, the concept of pain management with multimodal analgesia and regional anesthesia plays a crucial role in postoperative analgesia reducing opioids consumption and decreasing the time to mobilization. Numerous regional anesthetic techniques have been used, including patient-controlled epidural analgesia, intrathecal morphine, fascia iliaca block, lumber plexus block, sacral plexus block, and local infiltration analgesia. However, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for THA.
The ultrasound-guided (QL) block is a regional anesthetic technique that was initially proposed as an analgesic modality for abdominal surgery through many approaches: the lateral QL (QL1) block, the posterior QL (QL2) block, and the anterior QL (transmuscular) block The anterior QL block has been performed at the L3-L4 level also been used in hip surgery case reports.
A supra-iliac approach to the anterior QL block that is performed at a lower level than traditional anterior QL block approaches is considered a new approach discovered by Elsharkawy et al., and they found that a single injection between QL and Psoas muscle at the level of L5, successfully block the lumbar plexus and provide analgesia in patients undergoing total hip arthroplasty.
Anterior iliopsoas muscle space block is a new fascial block technique proposed by Dong et al., where the nerves of the lumbar plexus can be blocked by anterior injection in the iliopsoas space at the level of the anterior superior iliac spine and effectively provide perioperative analgesia for hip surgery.
This study will be designed to evaluate and compare the impact of these two fascial plane blocks for pre-emptive analgesia for patients undergoing total hip arthroplasty 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 be operated on under general anesthesia. Group IPS: patients will receive anterior IPS block with 30 ml of bupivacaine 0.25% followed by general anesthesia. Group Supra-iliac QL: patients will receive supra-iliac anterior QL block with 30 ml of bupivacaine 0.25% followed by general anesthesia.
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Procedure: controlpatients will be operated on under general anesthesia |
| IPS group | Active comparator | Procedure: IPSpatients will receive an ultrasound-guided anterior iliopsoas muscle space (IPS) block |
| Supra-iliac QL group | Active comparator | Procedure: Supra-iliac QLpatients will receive an ultrasound-guided supra-iliac anterior quadratus lumborum (QL) block |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient acceptance.
- Age 50-80 years old.
- BMI ≤ 30 kg/m2
- ASA I - III.
- Elective total hip arthroplasty under general anesthesia.
Key exclusion criteria (6 listed)
- History of allergy to the LA agents used in this study
- Skin lesion at the needle insertion site,
- Those with bleeding disorders, sepsis, liver disease, and psychiatric disorders
- Pre-existing neurological deficit in the lower extremity
- History of chronic pain and taking analgesics
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 |
|---|---|---|
| controlpatient will be operated under general anesthesia | Procedure or surgery | control group |
| IPSAlso: anterior iliopsoas muscle space blockpatients will receive ultrasound-guided anterior IPS block with 30 ml of bupivacaine 0.25% followed by general anesthesia. | Procedure or surgery | IPS group |
| Supra-iliac QLAlso: supra-iliac anterior quadratus lumborum blockpatients will receive ultrasound-guided supra-iliac anterior QL block with 30 ml of bupivacaine 0.25% followed by general anesthesia. | Procedure or surgery | Supra-iliac QL group |
Primary outcome
changes in Visual analogue scale (VAS)score
Time frame: measured at 1 hour, 3 hours,6 hours,12hours,18hours, 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
1 secondary outcome
Total dose of rescue analgesia
Time frame: in the first 24 hours 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 15 Jul 2025.
- Background: PubMed 30953311Elsharkawy H, El-Boghdadly K, Barnes TJ, Drake R, Maheshwari K, Soliman LM, Horn JL, Chin KJ. The supra-iliac anterior quadratus lumborum block: a cadaveric study and case series. Can J Anaesth. 2019 Aug;66(8):894-906. doi: 10.1007/s12630-019-01312-z. Epub 2019 Mar 11.
- Background: PubMed 33492871Dong J, Zhang Y, Chen X, Ni W, Yan H, Liu Y, Shi H, Jiang W, Zhao D, Xu T. Ultrasound-guided anterior iliopsoas muscle space block versus posterior lumbar plexus block in hip surgery in the elderly: A randomised controlled trial. Eur J Anaesthesiol. 2021 Apr 1;38(4):366-373. doi: 10.1097/EJA.0000000000001452.
- BackgroundChalacheewa, T, Termpornlert, S, Sa-Ngasoongsong P, Sangkum, Lisa. Regional Anesthesia for Hip Surgery Patients: Review Article. Journal of the Medical Association of Thailand 2022; 105: 152-9.
- BackgroundDangle J, Kukreja P, Kalagara H. Review of Current Practices of Peripheral Nerve Blocks for Hip Fracture and Surgery. Curr Anesthesiol Rep 2020; 10:259-66.
- Background: PubMed 27513972Hockett MM, Hembrador S, Lee A. Continuous Quadratus Lumborum Block for Postoperative Pain in Total Hip Arthroplasty: A Case Report. A A Case Rep. 2016 Sep 15;7(6):129-31. doi: 10.1213/XAA.0000000000000363.
- 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.
Shereen E Abd Ellatif, MD principal investigator
Faculty of medicine, zagazig university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPS and Supra-iliac QL in people with Hip Arthropathy, 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 6 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 15 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?
changes in Visual analogue scale (VAS)score (time frame: measured at 1 hour, 3 hours,6 hours,12hours,18hours, 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 NCT05556759, which also lists 5 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 15 Jul 2025.