Posterior Spinal Instrumentation PatientsEarly Phase 1NCT07711522
Quadro-Iliac Plane Block for Pain Control After Posterior Spinal Instrumentation Surgery
A Early Phase 1 study testing Fentanyl (IV), Meperidine and Paracetamol (acetaminophen) in people with Posterior Spinal Instrumentation Patients, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Posterior spinal instrumentation can cause significant postoperative pain due to extensive muscle dissection, manipulation of bone tissue, and implant placement. Providing optimal analgesia in the postoperative period is important for patients' functional recovery and early mobilization. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Posterior Spinal Instrumentation Patients
- What is being tested?
- Fentanyl (IV), Meperidine and Paracetamol (acetaminophen)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to Jul 2027
- Phase
- Early Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Posterior spinal instrumentation patients
Who cannot join
- Contraindications for regional analgesia
- Allergies for local anesthetics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Medipol Mega Hastaneler Kompleksi
Istanbul, Bagcilar, 34214
About this study
Official title: The Efficacy of Quadro-Iliac Plane Block for Postoperative Analgesia in Patients Undergoing Posterior Spinal Instrumentation Surgery: A Randomized Prospective Controlled Trial
Posterior spinal instrumentation can cause significant postoperative pain due to extensive muscle dissection, manipulation of bone tissue, and implant placement. Providing optimal analgesia in the postoperative period is important for patients' functional recovery and early mobilization. Inadequate control of postoperative pain may delay recovery, increase the risk of opioid dependence, and lead to respiratory complications.
Although opioid analgesics are effective in reducing pain during the postoperative period, they are associated with side effects such as nausea, vomiting, respiratory depression, and the risk of dependence. Therefore, the use of non-opioid analgesic approaches is important for patient safety and comfort. For these reasons, regional analgesia techniques such as the modified thoracolumbar interfascial plane (TLIP) block and the erector spinae plane (ESP) block have recently become increasingly popular for postoperative pain control. The quadro-iliac plane block is a novel technique that targets the attachment area of the posterior surface of the quadratus lumborum muscle on the inner surface of the iliac crest. In this block, the spread of local anesthetic along the fascial planes surrounding the quadratus lumborum muscle may provide an anatomical mechanism contributing to analgesia of the lumbosacral, paraspinal, lower abdominal, and gluteal regions. However, as the quadro-iliac plane block is a new technique, there are not yet sufficient studies on this topic in the literature.
The primary objective of our study is to evaluate the effect of ultrasound-guided quadro-iliac plane block (QIPB) on postoperative opioid consumption after posterior spinal instrumentation. The secondary objectives are to compare opioid-related side effects, such as nausea, vomiting, and respiratory depression, as well as postoperative NRS (Numeric Rating Scale) pain scores between the groups.
- Being tested
- Fentanyl (IV), Meperidine, Paracetamol (acetaminophen)
- Keywords
- Posterior spinal instrumentation, Postoperative analgesia, quadro-iliac plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl (IV)Drug
All patients will have an IV PCA with fentanyl.The PCA settings will consist of a 10-µg fentanyl bolus dose with a 10-minute lockout interval.
MeperidineDrug
If the patient's NRS is 4 or more even though 1 gr IV paracetamol and IV PCA, meperidine 0.5 mg/kg w'll be administered as rescue analgesic
Paracetamol (acetaminophen)Drug
An order for intravenous paracetamol 1 g every 8 hours will be placed for all patients.
| Study group | Role | What they receive |
|---|---|---|
| Quadro-iliac block group | Active comparator | Not described Receives: Drug: Fentanyl (IV); Drug: Meperidine; Drug: Paracetamol (acetaminophen) |
| Wound infiltration Group | Other | Not described Receives: Drug: Fentanyl (IV); Drug: Meperidine; Drug: Paracetamol (acetaminophen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of ultrasound-guided quadro-iliac plane block (QIPB) on postoperative opioid consumption f
The primary objective of this study is to evaluate the effect of ultrasound-guided quadro-iliac plane block (QIPB) on postoperative opioid consumption following posterior spinal instrumentation surgery.
Measured: Postoperative 24 hours
Secondary outcomes (2)
NRS of patients
Measured: Postoperative 24 hours
Opioid related adverse effects
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Posterior Spinal Instrumentation PatientsStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Pınar Uçar, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711522
- Sponsor's protocol ID
- PSEQIPB2026
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because there is no plan for public data sharing for this study.
Publications
Turan EI, Sahin AS. Quadro-iliac plane block (QIPB) in lumbar stabilisation surgeries: A case series. Indian J Anaesth. 2025 Feb;69(2):244-245. doi: 10.4103/ija.ija_1077_24. Epub 2025 Jan 29. No abstract available.
PubMed 40160919Ciftci B, Cetinkal A, Alver S, Ahiskalioglu A. Quadro-iliac plane block for lumbar multi-level instrumentation surgery: far away from the surgical area. Minerva Anestesiol. 2025 Apr;91(4):358-359. doi: 10.23736/S0375-9393.24.18680-4. Epub 2024 Dec 10. No abstract available.
PubMed 39656149Zamudio D, Fernandez L, Rodriguez A, Delgado D. Postoperative erector spinae plane block does not reduce morphine consumption after lumbar spinal fusion: A randomized controlled trial. J Clin Anesth. 2025 Nov;107:112022. doi: 10.1016/j.jclinane.2025.112022. Epub 2025 Sep 26.
PubMed 41014734
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Quadro-Iliac Plane Block for Postoperative Analgesia in Patients Undergoing Posterior Spinal Instrumentation Surgery: A Randomized Prospective Controlled Trial
- ClinicalTrials.gov ID
- NCT07711522
- Acronym / sponsor ID
- PSEQIPB2026
- Keywords
- Posterior spinal instrumentation, Postoperative analgesia, quadro-iliac plane block
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Jul 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.
Posterior spinal instrumentation can cause significant postoperative pain due to extensive muscle dissection, manipulation of bone tissue, and implant placement. Providing optimal analgesia in the postoperative period is important for patients' functional recovery and early mobilization. Inadequate control of postoperative pain may delay recovery, increase the risk of opioid dependence, and lead to respiratory complications.
Although opioid analgesics are effective in reducing pain during the postoperative period, they are associated with side effects such as nausea, vomiting, respiratory depression, and the risk of dependence. Therefore, the use of non-opioid analgesic approaches is important for patient safety and comfort. For these reasons, regional analgesia techniques such as the modified thoracolumbar interfascial plane (TLIP) block and the erector spinae plane (ESP) block have recently become increasingly popular for postoperative pain control. The quadro-iliac plane block is a novel technique that targets the attachment area of the posterior surface of the quadratus lumborum muscle on the inner surface of the iliac crest. In this block, the spread of local anesthetic along the fascial planes surrounding the quadratus lumborum muscle may provide an anatomical mechanism contributing to analgesia of the lumbosacral, paraspinal, lower abdominal, and gluteal regions. However, as the quadro-iliac plane block is a new technique, there are not yet sufficient studies on this topic in the literature.
The primary objective of our study is to evaluate the effect of ultrasound-guided quadro-iliac plane block (QIPB) on postoperative opioid consumption after posterior spinal instrumentation. The secondary objectives are to compare opioid-related side effects, such as nausea, vomiting, and respiratory depression, as well as postoperative NRS (Numeric Rating Scale) pain scores between the groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadro-iliac block group | Active comparator | Drug: Fentanyl (IV), Drug: Meperidine, Drug: Paracetamol (acetaminophen) |
| Wound infiltration Group | Other | Drug: Fentanyl (IV), Drug: Meperidine, Drug: Paracetamol (acetaminophen) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Posterior spinal instrumentation patients
Key exclusion criteria (2 listed)
- Contraindications for regional analgesia
- Allergies for local anesthetics
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 |
|---|---|---|
| Fentanyl (IV)All patients will have an IV PCA with fentanyl.The PCA settings will consist of a 10-µg fentanyl bolus dose with a 10-minute lockout interval. | Drug | Quadro-iliac block group, Wound infiltration Group |
| MeperidineIf the patient's NRS is 4 or more even though 1 gr IV paracetamol and IV PCA, meperidine 0.5 mg/kg w'll be administered as rescue analgesic | Drug | Quadro-iliac block group, Wound infiltration Group |
| Paracetamol (acetaminophen)An order for intravenous paracetamol 1 g every 8 hours will be placed for all patients. | Drug | Quadro-iliac block group, Wound infiltration Group |
Primary outcome
The effect of ultrasound-guided quadro-iliac plane block (QIPB) on postoperative opioid consumption f
Time frame: Postoperative 24 hours
The primary objective of this study is to evaluate the effect of ultrasound-guided quadro-iliac plane block (QIPB) on postoperative opioid consumption following posterior spinal instrumentation surgery.
2 secondary outcomes
NRS of patients
Time frame: Postoperative 24 hours
Opioid related adverse effects
Time frame: Postoperative 24 hours
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 28 Aug 2026.
- Results publication: PubMed 40160919Turan EI, Sahin AS. Quadro-iliac plane block (QIPB) in lumbar stabilisation surgeries: A case series. Indian J Anaesth. 2025 Feb;69(2):244-245. doi: 10.4103/ija.ija_1077_24. Epub 2025 Jan 29. No abstract available.
- Results publication: PubMed 39656149Ciftci B, Cetinkal A, Alver S, Ahiskalioglu A. Quadro-iliac plane block for lumbar multi-level instrumentation surgery: far away from the surgical area. Minerva Anestesiol. 2025 Apr;91(4):358-359. doi: 10.23736/S0375-9393.24.18680-4. Epub 2024 Dec 10. No abstract available.
- Results publication: PubMed 41014734Zamudio D, Fernandez L, Rodriguez A, Delgado D. Postoperative erector spinae plane block does not reduce morphine consumption after lumbar spinal fusion: A randomized controlled trial. J Clin Anesth. 2025 Nov;107:112022. doi: 10.1016/j.jclinane.2025.112022. Epub 2025 Sep 26.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because there is no plan for public data sharing for this study.
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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 Early Phase 1 study testing Fentanyl (IV), Meperidine and Paracetamol (acetaminophen) in people with Posterior Spinal Instrumentation Patients, run by Istanbul Medipol University 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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 28 Aug 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 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 P Ucar (+90 537 769 72 81, fpinarucar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of ultrasound-guided quadro-iliac plane block (QIPB) on postoperative opioid consumption f (time frame: Postoperative 24 hours). 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 NCT07711522, which also lists 3 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 28 Aug 2026.