Postoperative PainNCT06870071
Effect of Quadro-Iliac Plane Block on Recovery After Total Hip Arthroplasty
A study testing Quadro iliac plane block in people with Postoperative Pain, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Total hip arthroplasty is a widely performed surgical procedure in the elderly population, aiming to relieve hip joint pain and restore function. Total hip arthroplasty is among the most critical surgical procedures in terms of morbidity and mortality within this demographic. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Quadro iliac plane block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2025to 25 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral THA.
- Spinal anesthesia.
- Age 18-85 years.
- ASA classification I-IV.
Who cannot join
- Patients who declined consent.
- Contraindications to regional anesthesia.
- Coagulation disorders.
- Infections at the block site.
- Emergency surgeries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Quadro-Iliac Plane Block on Quality of Recovery After Total Hip Arthroplasty: A Prospective, Randomized, Controlled, Double-Blind, Multicenter Study
Total hip arthroplasty is a widely performed surgical procedure in the elderly population, aiming to relieve hip joint pain and restore function. Total hip arthroplasty is among the most critical surgical procedures in terms of morbidity and mortality within this demographic. To mitigate opioid-related adverse effects in this patient group, novel analgesic methods are needed. Regional anesthesia techniques used for postoperative pain management include epidural analgesia, lumbar plexus block, fascia iliaca block, femoral and obturator nerve blocks, and sacral erector spinae plane block. However, these procedures may result in complications such as epidural hematoma, postoperative headache, prolonged motor block, and extended hospital stay.
Read the detailed description
Total hip arthroplasty is a widely performed surgical procedure in the elderly population, aiming to relieve hip joint pain and restore function. Total hip arthroplasty is among the most critical surgical procedures in terms of morbidity and mortality within this demographic. To mitigate opioid-related adverse effects in this patient group, novel analgesic methods are needed. Regional anesthesia techniques used for postoperative pain management include epidural analgesia, lumbar plexus block, fascia iliaca block, femoral and obturator nerve blocks, and sacral erector spinae plane block. However, these procedures may result in complications such as epidural hematoma, postoperative headache, prolonged motor block, and extended hospital stay.
Recently, Tulgar et al. introduced a novel fascial plane block called the "quadro-iliac plane block". This block is performed in the quadro-iliac plane, located between the inner surface of the iliac crest and the posterior surface of the quadratus lumborum muscle. In their study, Tulgar et al. bilaterally injected 40 mL of methylene blue into the quadro-iliac plane, observing widespread dye distribution along the posterior and anterior surfaces of the quadratus lumborum muscle, transversalis fascia, ilioinguinal, iliohypogastric, subcostal, and genitofemoral nerves, as well as the lumbar plexus. Based on these findings, quadro-iliac plane block has been proposed as a potentially effective technique for managing acute or chronic pain in the lumbosacral, abdominal, and hip regions. However, apart from a few case reports involving lumbar spine surgery and kidney transplantation, evidence regarding the efficacy of quadro-iliac plane block remains limited.
- Conditions
- Postoperative Pain
- Being tested
- Control group, Quadro iliac plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
IV paracetamol (1 g, 3×1) and IV dexketoprofen (50 mg, 2×1)
Quadro iliac plane blockOther
40 mL of 0.25% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | IV paracetamol (1 g, 3×1) and IV dexketoprofen (50 mg, 2×1) Receives: Other: Quadro iliac plane block |
| Quadro iliac plane block | Active comparator | 40 mL of 0.25% bupivacaine Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Quality of Recovery-15
The primary outcome was the Quality of Recovery-15 score at 24 hours postoperatively. QoR-15 scores range from 0 to 150, with higher scores indicating better recovery quality.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start11 Mar 2025
- Primary completion25 Apr 2025
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Halit Satici, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870071
- Sponsor's protocol ID
- Quadro-Iliac Block Hip
- Status last verified
- Apr 2025
- First submitted
- 5 Mar 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Quadro-Iliac Plane Block on Quality of Recovery After Total Hip Arthroplasty: A Prospective, Randomized, Controlled, Double-Blind, Multicenter Study
- ClinicalTrials.gov ID
- NCT06870071
- Acronym / sponsor ID
- Quadro-Iliac Block Hip
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 11 Mar 2025 (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 is a widely performed surgical procedure in the elderly population, aiming to relieve hip joint pain and restore function. Total hip arthroplasty is among the most critical surgical procedures in terms of morbidity and mortality within this demographic. To mitigate opioid-related adverse effects in this patient group, novel analgesic methods are needed. Regional anesthesia techniques used for postoperative pain management include epidural analgesia, lumbar plexus block, fascia iliaca block, femoral and obturator nerve blocks, and sacral erector spinae plane block. However, these procedures may result in complications such as epidural hematoma, postoperative headache, prolonged motor block, and extended hospital stay.
Detailed description
Total hip arthroplasty is a widely performed surgical procedure in the elderly population, aiming to relieve hip joint pain and restore function. Total hip arthroplasty is among the most critical surgical procedures in terms of morbidity and mortality within this demographic. To mitigate opioid-related adverse effects in this patient group, novel analgesic methods are needed. Regional anesthesia techniques used for postoperative pain management include epidural analgesia, lumbar plexus block, fascia iliaca block, femoral and obturator nerve blocks, and sacral erector spinae plane block. However, these procedures may result in complications such as epidural hematoma, postoperative headache, prolonged motor block, and extended hospital stay.
Recently, Tulgar et al. introduced a novel fascial plane block called the "quadro-iliac plane block". This block is performed in the quadro-iliac plane, located between the inner surface of the iliac crest and the posterior surface of the quadratus lumborum muscle. In their study, Tulgar et al. bilaterally injected 40 mL of methylene blue into the quadro-iliac plane, observing widespread dye distribution along the posterior and anterior surfaces of the quadratus lumborum muscle, transversalis fascia, ilioinguinal, iliohypogastric, subcostal, and genitofemoral nerves, as well as the lumbar plexus. Based on these findings, quadro-iliac plane block has been proposed as a potentially effective technique for managing acute or chronic pain in the lumbosacral, abdominal, and hip regions. However, apart from a few case reports involving lumbar spine surgery and kidney transplantation, evidence regarding the efficacy of quadro-iliac plane block remains limited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Quadro iliac plane blockIV paracetamol (1 g, 3×1) and IV dexketoprofen (50 mg, 2×1) |
| Quadro iliac plane block | Active comparator | Other: Control group40 mL of 0.25% bupivacaine |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral THA.
- Spinal anesthesia.
- Age 18-85 years.
- ASA classification I-IV.
Key exclusion criteria (5 listed)
- Patients who declined consent.
- Contraindications to regional anesthesia.
- Coagulation disorders.
- Infections at the block site.
- Emergency surgeries.
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 |
|---|---|---|
| Control groupIV paracetamol (1 g, 3×1) and IV dexketoprofen (50 mg, 2×1) | Other | Quadro iliac plane block |
| Quadro iliac plane block40 mL of 0.25% bupivacaine | Other | control group |
Primary outcome
Postoperative Quality of Recovery-15
Time frame: 24 hours
The primary outcome was the Quality of Recovery-15 score at 24 hours postoperatively. QoR-15 scores range from 0 to 150, with higher scores indicating better recovery quality.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadro iliac plane block in people with Postoperative Pain, run by Konya City Hospital at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 27 Apr 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 Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative Quality of Recovery-15 (time frame: 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 27 Apr 2025.