- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07711522
Quadro-Iliac Plane Block for Pain Control After Posterior Spinal Instrumentation Surgery
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Fatma P Ucar
- Telefonnummer: +90 537 769 72 81
- E-mail: fpinarucar@gmail.com
Studiesteder
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Bagcilar
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Istanbul, Bagcilar, Tyrkiet (Türkiye), 34214
- Medipol Mega Hastaneler Kompleksi
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria: Posterior spinal instrumentation patients -
Exclusion Criteria: Contraindications for regional analgesia, allergies for local anesthetics
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Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Quadro-iliac block group
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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.
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
An order for intravenous paracetamol 1 g every 8 hours will be placed for all patients.
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Andet: Wound infiltration Group
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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.
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
An order for intravenous paracetamol 1 g every 8 hours will be placed for all patients.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The effect of ultrasound-guided quadro-iliac plane block (QIPB) on postoperative opioid consumption f
Tidsramme: Postoperative 24 hours
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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.
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Postoperative 24 hours
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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NRS of patients
Tidsramme: Postoperative 24 hours
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Postoperative 24 hours
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Opioid related adverse effects
Tidsramme: Postoperative 24 hours
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Postoperative 24 hours
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- 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.
- Ciftci 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.
- Zamudio 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PSEQIPB2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Posterior Spinal Instrumentation Patients
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Joseph D. TobiasAfsluttetPosterior Spinal FusionForenede Stater
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Shriners Hospitals for ChildrenSuspenderetPosterior Spinal FusionForenede Stater, Canada
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Yonsei UniversityAfsluttetElektiv Posterior Lumbal Spinal FusionKorea, Republikken
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Rush University Medical CenterRekrutteringÅbn posterior Thoracolumbar Spinal Fusion ProcedureForenede Stater
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The Third Affiliated Hospital of Guangzhou Medical...RekrutteringUltralyd | Spinal anæstesi | Posterior Superior Iliac Spine | Interkristal linjeKina
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Eskisehir Osmangazi UniversityAfsluttetSpinal anæstesi | Hoftekirurgi | Geriatrisk patientTyrkiet (Türkiye)
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University of Puerto RicoAfsluttetSmertebehandling | Posterior Spinal FusionPuerto Rico
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University of Colorado, DenverAfsluttetTeenagers idiopatisk skoliose | Posterior Spinal FusionForenede Stater
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Xijing HospitalRekrutteringForsker i brugen af Barb Sutur hos overvægtige patienter, der gennemgår posterior cervikal kirurgiCervikal spinal stenose | Posterior cervikal rygsøjlekirurgi | Pigtforsynet suturKina
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University of Colorado, DenverAfsluttetTeenagers idiopatisk skoliose | Posterior Spinal FusionForenede Stater
Kliniske forsøg med Fentanyl (IV)
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Assiut UniversityIkke rekrutterer endnu
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Horizon Health NetworkTilmelding efter invitationEkstrakorporeal Shockwave LithotripsiCanada
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Cairo UniversityRekrutteringKetamin | Koronararteriesygdom (CAD) | Fentanyl | Lidokain | Venstre ventrikulær (LV) systolisk dysfunktion | Koronar bypass transplantatkirurgi | InduktionsanæstesiEgypten
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Kaohsiung Medical University Chung-Ho Memorial...Ukendt
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Cairo UniversityIkke rekrutterer endnuAkut abdominal kirurgi | Opioidbesparende anæstesiEgypten
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Ankara City Hospital BilkentAfsluttetForhøjet blodtryk | TakykardiTyrkiet (Türkiye)
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Istanbul University - CerrahpasaIkke rekrutterer endnuGrå stærTyrkiet (Türkiye)
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Children's Cancer Hospital Egypt 57357Aktiv, ikke rekrutterendeEpilepsi | Hjerne svulstEgypten
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Cairo UniversityKasr El Aini HospitalAktiv, ikke rekrutterende