Quadro-Iliac Plane Block for Analgesia After Lumbar Microdiscectomy (QIPB RCT)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Engin ihsan Turan, principal investigator
- Numéro de téléphone: +905382431114
- E-mail: drenginihsan@gmail.com
Lieux d'étude
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Istanbul
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Istanbul, Istanbul, Turquie (Türkiye), 34303
- Recrutement
- Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
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Contact:
- Engin ihsan Turan
- Numéro de téléphone: 05382431114
- E-mail: enginihsan@hotmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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.
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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.
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Comparateur actif: Local Infiltration Analgesia Group
Participants in this group will receive surgeon-performed local infiltration analgesia, followed by postoperative fentanyl-based patient-controlled analgesia.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Total Fentanyl Consumption During the First 24 Hours After Surgery
Délai: Postoperative 0-24 hours
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Total postoperative fentanyl consumption administered via patient-controlled analgesia will be recorded during the first 24 hours after surgery.
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Postoperative 0-24 hours
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Postoperative Pain Scores at Rest and During Movement
Délai: Postoperative 0, 1, 6, 12, and 24 hours
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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.
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Postoperative 0, 1, 6, 12, and 24 hours
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Opioid-Related Adverse Effects
Délai: Postoperative 0-24 hours
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Opioid-related adverse effects, including nausea, vomiting, pruritus, and respiratory depression, will be recorded.
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Postoperative 0-24 hours
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Dermatomal Sensory Spread
Délai: Postoperative 2 hours
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Dermatomal sensory spread of the block will be evaluated using a cold test.
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Postoperative 2 hours
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Number of Patients Require Rescue Analgesic
Délai: Postoperative 0-24 hours
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The need for rescue analgesia with intravenous tenoxicam will be recorded during the postoperative follow-up period.
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Postoperative 0-24 hours
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Quality of Recovery Score
Délai: Postoperative 24 hours
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Patient-reported recovery quality will be assessed using the Quality of Recovery-15 questionnaire (0-150).
Higher value means better Quality of Recovery.
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Postoperative 24 hours
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Quadroiliac plane block RCT
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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