- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07348419
Quadro-Iliac vs Thoracolumbar Interfascial Plane Block för Analgesi Efter Ennivå Lumbal Diskoperation
Jämförelse av postoperativ smärtlindrande effekt av Quadro-Iliac Plan Block och klassisk Thoracolumbar Interfascial Plan Block vid enkelnivå lumbal diskoperation: En prospektiv randomiserad kontrollerad studie
The investigators aim to compare the postoperative analgesic efficacy of the classical thoracolumbar interfascial plane block and the Quadro-iliac plane block for postoperative analgesia management after lumbar disc surgery.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Lumbar spinal stenosis can lead to variable signs and symptoms such as back pain, radiating pain to the lower extremities, and reduced walking capacity. Lumbar disc surgery itself causes significant pain due to extensive dissection and muscle retraction during the procedure. A multimodal analgesic approach is preferred for postoperative pain management after lumbar spine surgery. The addition of regional anesthesia techniques can reduce opioid-related side effects and is associated with earlier mobilization, shorter hospital stay, and improved patient satisfaction.
For patients undergoing lumbar disc surgery, the classical thoracolumbar interfascial plane (TLIP) block and the Quadro-iliac plane block (QIPB) provide effective analgesia for postoperative pain control.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Samsun, Turkiet (Türkiye)
- Samsun University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients aged 18-70 years,
- Classified as ASA physical status I-III,
- Scheduled to undergo single-level lumbar spinal surgery under general anesthesia
- Who agree to participate in the study by providing written informed consent
Exclusion Criteria:
- History of bleeding diathesis or current anticoagulant therapy
- Known allergy or hypersensitivity to local anesthetics or opioid medications
- Infection at the planned block injection site
- Previous lumbar spine surgery
- History of gabapentinoid or corticosteroid use within the last 3 weeks
- Inability to use a patient-controlled analgesia (PCA) device
- Suspected pregnancy, confirmed pregnancy, or breastfeeding
- Refusal to undergo the procedure or to participate in the study
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: Active Comparator: Group QİPB
The Quadro-iliac plane block will be performed 30 minutes before lumbar spine surgery |
Quadro-iliac plane block will be performed under ultrasound guidance before the induction of general anesthesia. |
|
Övrig: Active Comparator: Group TLİP
The classical thoracolumbar interfascial plane (TLIP) block will be performed 30 minutes before lumbar spine surgery. |
Classical thoracolumbar interfascial plane block will be performed under ultrasound guidance before the induction of general anesthesia. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Opioid consumption
Tidsram: 24 hours
|
In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups. |
24 hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Perioperative pain intensity
Tidsram: 24 hours
|
Changes in the Numerical Rating Scale (NRS) will be recorded at rest and during movement. The participant's baseline NRS will be recorded, followed by measurements before and after neuraxial positioning and up to 24 hours post-surgery. The NRS is a unidimensional measure of pain intensity in adults. It is a segmented numerical version of the Visual Analog Scale (VAS) where the participant selects a whole number (0-10) that best represents the intensity of their pain. The 11-point numerical scale ranges from '0' representing one end of the pain spectrum (e.g. 'no pain') to '10' representing the other end (e.g. 'worst imaginable pain'). |
24 hours
|
|
Postoperative nausea and vomiting
Tidsram: 24 hours
|
Postoperative nausea and vomiting (PONV): During follow-up, patients who experience nausea or vomiting will be evaluated using a verbal descriptive PONV scale (0=None, 1=Mild nausea, 2=Moderate nausea, 3=Single episode of vomiting, 4=More than one episode of vomiting). |
24 hours
|
|
Quality of recovery 15 scale
Tidsram: 24 hours after surgery
|
Postoperative Quality of Recovery 15 in Turkish scale. The QoR-15 (Quality of Recovery-15) questionnaire is a simple and practical tool used to assess postoperative recovery. It consists of 15 items, each scored on a numeric scale from 0 to 10, resulting in a total score ranging from 0 to 150. Based on the total score, postoperative recovery is categorized as follows: 136-150: Excellent recovery 122-135: Good recovery 90-121: Moderate recovery 0-89: Poor recovery |
24 hours after surgery
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Hale KEFELI CELIK, M.D., Samsun University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- OMUKAEK 2025/279
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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