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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Engin ihsan Turan, principal investigator
- Telefoonnummer: +905382431114
- E-mail: drenginihsan@gmail.com
Studie Locaties
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Istanbul
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Istanbul, Istanbul, Turkije (Türkiye), 34303
- Werving
- Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
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Contact:
- Engin ihsan Turan
- Telefoonnummer: 05382431114
- E-mail: enginihsan@hotmail.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Total Fentanyl Consumption During the First 24 Hours After Surgery
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Postoperative Pain Scores at Rest and During Movement
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Quadroiliac plane block RCT
Plan Individuele Deelnemersgegevens (IPD)
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