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Recruiting NCT07712783

NCT07712783 Lateral QL Block vs Intrathecal Morphine for Cesarean Section

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Clinical Trial Summary
NCT ID NCT07712783
Status Recruiting
Phase —
Sponsor Ondokuz Mayıs University
Condition Anesthesia
Study Type INTERVENTIONAL
Enrollment 56 participants
Start Date 2026-07-15
Primary Completion 2027-01-01

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age 45 Years
Study Type INTERVENTIONAL
Interventions
Lateral Quadratus Lumborum Blockıv morphine PCAIntrathecal morphine

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 56 participants in total. It began in 2026-07-15 with a primary completion date of 2027-01-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 Criteria

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.

Contact & Investigator

Central Contact

Burhan Dost

✉ burhandost@hotmail.com

📞 +903623121919

Principal Investigator

Burhan Dost

PRINCIPAL INVESTIGATOR

Ondokuz Mayıs University

Frequently Asked Questions

Who can join the NCT07712783 clinical trial?

This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07712783 currently recruiting?

Yes, NCT07712783 is actively recruiting participants. Contact the research team at burhandost@hotmail.com for enrollment information.

Where is the NCT07712783 trial being conducted?

This trial is being conducted at Samsun, Turkey (Türkiye).

Who is sponsoring the NCT07712783 clinical trial?

NCT07712783 is sponsored by Ondokuz Mayıs University. The principal investigator is Burhan Dost at Ondokuz Mayıs University. The trial plans to enroll 56 participants.

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