Subcutaneous Methadone for Cesarean Analgesia: a Non Inferiority Study Using QoR-10

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorClinica Alemana de Santiago

About this trial

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

Qualifiers

Women aged 18-45 years

Singleton pregnancy at term (≥37 weeks of gestation)

Scheduled for elective cesarean delivery

Planned neuraxial spinal anesthesia

Disqualifiers

Emergency cesarean delivery

Contraindication to neuraxial anesthesia

Known hypersensitivity or allergy to methadone or morphine

Chronic opioid use or opioid dependence

Trial design

Treatments tested in this trial

  • Methadone 0.15 mg/kg
  • morphine

Treatment groups

128 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators