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NCT07777029
Subcutaneous Methadone for Cesarean Analgesia: a Non Inferiority Study Using QoR-10
Conditions: Cesarean Section Pain
Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: No
Phase: NA
Enrollment: 128
Sponsor: Clinica Alemana de Santiago
Summary
This study aims to evaluate whether subcutaneous methadone provides postoperative analgesia that is non-inferior to that achieved with intrathecal morphine in women undergoing cesarean delivery under neuraxial anesthesia. The primary outcome will be the quality of postoperative recovery, assessed using the QoR-10 score during the first 24 hours after surgery. Secondary outcomes will include postoperative pain intensity, opioid consumption, incidence of adverse effects, and maternal satisfaction.
This trial seeks to determine whether subcutaneous methadone could represent an alternative analgesic strategy within multimodal analgesia protocols for cesarean delivery.
Eligibility Criteria
Inclusion Criteria:
* Women aged 18-45 years
* Singleton pregnancy at term (≥37 weeks of gestation)
* Scheduled for elective cesarean delivery
* Planned neuraxial spinal anesthesia
* Ability to understand and complete the QoR-10 questionnaire
* Provision of written informed consent
Exclusion Criteria:
* Emergency cesarean delivery
* Contraindication to neuraxial anesthesia
* Known hypersensitivity or allergy to methadone or morphine
* Chronic opioid use or opioid dependence
Source: ClinicalTrials.gov (NCT07777029). StuddyBuddy aggregates publicly available trial information.