💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
HealthTeky