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Quadro-Iliac Plane Block for Analgesia After Lumbar Microdiscectomy (QIPB RCT)

29. juli 2026 oppdatert av: Engin Ihsan Turan, Kanuni Sultan Suleyman Training and Research Hospital

Effect of Ultrasound-Guided Quadro-Iliac Plane Block Compared With Local Infiltration Analgesia After Single-Level Lumbar Microdiscectomy: A Prospective, Double-Blind, Controlled, Multicenter Randomized Trial

This study will evaluate whether ultrasound-guided quadro-iliac plane block provides better postoperative pain control than local infiltration analgesia in patients undergoing single-level lumbar microdiscectomy.

Adult patients scheduled for elective single-level lumbar microdiscectomy will be randomly assigned to receive either bilateral quadro-iliac plane block plus patient-controlled analgesia or local infiltration analgesia plus patient-controlled analgesia. The main outcome of the study will be total fentanyl consumption during the first 24 hours after surgery. Pain scores, need for rescue analgesia, opioid-related side effects, patient satisfaction, and recovery quality will also be evaluated.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a prospective, randomized, double-blind, controlled, multicenter clinical trial designed to assess the analgesic efficacy of ultrasound-guided quadro-iliac plane block in patients undergoing elective single-level lumbar microdiscectomy.

Patients aged 18-75 years with American Society of Anesthesiologists physical status I-III who are scheduled for elective single-level lumbar microdiscectomy under general anesthesia will be included. Participants will be randomized into two groups. The intervention group will receive bilateral ultrasound-guided quadro-iliac plane block before emergence from anesthesia, followed by postoperative patient-controlled analgesia. The control group will receive local infiltration analgesia performed by the surgeon, followed by postoperative patient-controlled analgesia.

All patients will receive a standardized general anesthesia protocol. Postoperative analgesia will be provided using a fentanyl-based patient-controlled analgesia device. The primary outcome will be total fentanyl consumption during the first postoperative 24 hours. Secondary outcomes will include numerical rating scale pain scores at predefined postoperative time points, rescue analgesic requirement, opioid-related adverse effects such as nausea, vomiting, pruritus and respiratory depression, dermatomal sensory spread, and patient-reported recovery quality using the QoR-15 questionnaire.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Tyrkia (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Tyrkia (Türkiye), 34303
        • Rekruttering
        • Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Adults aged 18 to 75 years
  • American Society of Anesthesiologists physical status I to III
  • Scheduled for elective single-level lumbar microdiscectomy, such as L4-L5 or L5-S1 disc herniation
  • Planned surgery under general anesthesia
  • Able to provide written informed consent

Exclusion Criteria:

  • Allergy or hypersensitivity to local anesthetics
  • Coagulopathy or active anticoagulant use
  • Infection, scar tissue, or skin lesion at the injection site
  • Pregnancy or breastfeeding
  • Chronic pain syndrome or regular opioid use
  • American Society of Anesthesiologists physical status IV or higher
  • Planned surgery for two or more levels of disc herniation

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Quadro-Iliac Plane Block Group
Participants in this group will receive bilateral ultrasound-guided quadro-iliac plane block before emergence from general anesthesia, followed by postoperative fentanyl-based patient-controlled analgesia.
Fremgangsmåte: Ultrasound-Guided Quadro-Iliac Plane Block
Bilateral ultrasound-guided quadro-iliac plane block will be performed before emergence from general anesthesia in the prone position. After visualization of the quadratus lumborum muscle and iliac crest at the L3 level, 30 mL of 0.167% bupivacaine will be injected into the interfascial plane on each side. All participants will receive postoperative fentanyl-based patient-controlled analgesia.
Aktiv komparator: Local Infiltration Analgesia Group
Participants in this group will receive surgeon-performed local infiltration analgesia, followed by postoperative fentanyl-based patient-controlled analgesia.
Fremgangsmåte: Local Infiltration Analgesia (LIA)
Local infiltration analgesia will be performed by the surgeon before the end of surgery. A total dose of 50 mg of 0.25% bupivacaine will be infiltrated into the subcutaneous tissue. All participants will receive postoperative fentanyl-based patient-controlled analgesia.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total Fentanyl Consumption During the First 24 Hours After Surgery
Tidsramme: Postoperative 0-24 hours
Total postoperative fentanyl consumption administered via patient-controlled analgesia will be recorded during the first 24 hours after surgery.
Postoperative 0-24 hours

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative Pain Scores at Rest and During Movement
Tidsramme: Postoperative 0, 1, 6, 12, and 24 hours
Pain intensity will be assessed using the Numerical Rating Scale at rest and during movement. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Postoperative 0, 1, 6, 12, and 24 hours
Opioid-Related Adverse Effects
Tidsramme: Postoperative 0-24 hours
Opioid-related adverse effects, including nausea, vomiting, pruritus, and respiratory depression, will be recorded.
Postoperative 0-24 hours
Dermatomal Sensory Spread
Tidsramme: Postoperative 2 hours
Dermatomal sensory spread of the block will be evaluated using a cold test.
Postoperative 2 hours
Number of Patients Require Rescue Analgesic
Tidsramme: Postoperative 0-24 hours
The need for rescue analgesia with intravenous tenoxicam will be recorded during the postoperative follow-up period.
Postoperative 0-24 hours
Quality of Recovery Score
Tidsramme: Postoperative 24 hours
Patient-reported recovery quality will be assessed using the Quality of Recovery-15 questionnaire (0-150). Higher value means better Quality of Recovery.
Postoperative 24 hours

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

10. juli 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

2. desember 2026

Datoer for studieregistrering

Først innsendt

6. juli 2026

Først innsendt som oppfylte QC-kriteriene

6. juli 2026

Først lagt ut (Faktiske)

10. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Quadroiliac plane block RCT

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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