Lateral Quadratus Lumborum Block vs Intrathecal Morphine for Cesarean Section analgesia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, non-inferiority trial compares ultrasound-guided lateral QLB-I with intrathecal morphine for post-cesarean analgesia. Primary outcome focuses on analgesic efficacy, with secondary outcomes including opioid use after surgery, pain scores, opioid-related side effects, quality of recovery, and maternal satisfaction. The trial targets term, healthy-appearing, singleton pregnancies undergoing elective cesarean with spinal anesthesia. It aims to determine if QLB-I can match ITM in pain control while potentially reducing opioid-related adverse events. Safety monitoring aligns with standard perioperative analgesia trials.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ondokuz Mayis University
  Samsun, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Burhan Dost — Ondokuz Mayıs University
• Study coordinator: Burhan Dost
• Email: burhandost@hotmail.com
• Phone: +903623121919

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.