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Clinical Trials in Turkey / NCT07712783
Starting soon Not applicable

Lateral QL Block vs Intrathecal Morphine for Cesarean Section

NCT07712783 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-07-15
Last updated
2026-07-17

Condition(s) studied

AnesthesiaPostoperative PainRegional Anesthesia

Investigational drug(s) / intervention(s)

Lateral Quadratus Lumborum Blockıv morphine PCAIntrathecal morphine

Lateral Quadratus Lumborum Block: Active Lateral QLB Local anesthetic: 0.25% bupivacaine, 0.4 mL/kg perside (maximum 30 mL per side). Maximum total dose: Bupivacaine ≤2.5 mg/kg (maximum approximately 150 mg). Timing: Immediately after completion of surgery. The patient will be positioned supine or in a slight lateral decubitus position. A high-frequency linear US transducer (5-12 MHz) will be placed on the anterolateral abdominal wall at the T12-L1 level. The fascial plane will be identified under ultrasound guidance. A 22-gauge, 100-mm needle will be advanced using an in-plane approach, and after negative aspiration, the local anesthetic will be injected incrementally with hydrodissection confirming correct spread. Sham ITM: The spinal anesthesia technique will be identical to that of the active ITM group. Morphine will be replaced with 0.2 mL preservative-free normal saline, while maintaining an identical syringe volume (2.7 mL) and appearance.

ıv morphine PCA: A standardized IV PCA protocol will be initiated for all patients using a PCA device (Body Guard 575 pain manager, UK), programmed to deliver morphine boluses of 0.01-0.015 mg/kg (IBW), with a 6-minute lockout and a 4-hour maximum dose of 0.1-0.15 mg/ kg (IBW). No basal infusion will be used.

Intrathecal morphine: Hyperbaric 0.5% bupivacaine 12.5 mg, fentanyl 20 µg, and morphine 80 µg (0.08 mg). Spinal anesthesia will be performed at the L3-L4 or L4-L5 intervertebral space using a 25-gauge Quincke spinal needle. The study solution will be prepared to a total volume of 2.7 mL. Sham QLB Following completion of surgery, the patient will be positioned in the lateral decubitus position. The ultrasound transducer will be placed over the lateral QLB scanning window. A 22-gauge needle will be advanced into the skin and subcutaneous tissue only, without entering the fascial plane. To maintain procedural standardization and preserve blinding, 1-2 mL of normal saline will be injected into the subcutaneous tissue. Procedure duration, patient positioning, ultrasound probe placement, and dressing application will be identical to those used for the active lateral QLB-I procedure. A sterile dressing will be applied at the end of the procedure.

Study summary

Effective postoperative analgesia after cesarean delivery is essential for maternal recovery, early mobilization, breastfeeding, and maternal-infant bonding. Although intrathecal morphine (ITM) is considered the gold standard for post-cesarean analgesia, its use is associated with opioid-related adverse effects. Ultrasound-guided lateral quadratus lumborum block (QLB-I) has emerged as a promising alternative. This randomized, double-blind, non-inferiority trial aims to compare the postoperative analgesic efficacy of lateral QLB-I with ITM. Secondary outcomes include postoperative opioid consumption, pain scores, opioid-related adverse effects, quality of recovery (ObsQoR-11T), and maternal satisfaction.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria: * Women aged between 18 and 45 years. * Singleton term pregnancy (≥37 weeks of gestation). * American Society of Anesthesiologists (ASA) physical status II. * Scheduled to undergo elective cesarean delivery via a Pfannenstiel incision. * Planned to receive spinal anesthesia for cesarean delivery. * Provision of written informed consent following a comprehensive explanation of the study. * Sufficient cognitive capacity to understand and complete the study assessment instruments, including the Numeric Rating Scale (NRS) and the ObsQoR-11T. Exclusion Criteria: * Known allergy or hypersensitivity to any of the study medications, including morphine, bupivacaine, or fentanyl. * Coagulopathy (international normalized ratio \[INR\] \>1.5 or platelet count \<100,000/mm³). * Current treatment with anticoagulant or antiplatelet agents (e.g., heparin, low-molecular-weight heparin, or aspirin \>100 mg/day). * Infection, hematoma, or skin lesion at the planned block insertion site. * Diagnosis of preeclampsia, eclampsia, or HELLP syndrome. * Placenta previa, placenta accreta spectrum, or placental abruption. * Gestational diabetes mellitus or chronic hypertension. * Emergency cesarean delivery indicated because of fetal distress. * Conversion to general anesthesia during cesarean delivery. * History of chronic pain syndrome (e.g., fibromyalgia, lumbar disc herniation, or neuropathic pain). * Regular use of opioids or psychotropic medications within the preceding 3 months. * Diagnosis of epilepsy, severe anxiety disorder, or major depressive disorder. * Obesity (body mass index \>35 kg/m²). * Severe systemic disease, including New York Heart Association (NYHA) class III or IV heart failure, hepatic or renal failure, advanced respiratory disease, or obstructive sleep apnea. * Advanced pulmonary disease requiring continuous positive airway pressure (CPAP) therapy. * Inadequate spinal anesthesia or the requirement for supplemental intraoperative analgesia. * Surgical duration exceeding 120 minutes. * Excessive intraoperative blood loss (≥1,000 mL) or the need for blood transfusion.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ondokuz Mayis University Samsun Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07712783 on ClinicalTrials.gov ↗ ← All trials in Turkey