Subcutaneous Methadone for Cesarean Analgesia: a Non Inferiority Study Using QoR-10
NCT07777029 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128
Last updated 2026-08-20
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.
Conditions
- Cesarean Section Pain
Interventions
- DRUG
-
Methadone 0.15 mg/kg
Subcutaneous methadone administered for postoperative analgesia following cesarean delivery under neuraxial anesthesia.
- DRUG
-
morphine
Intrathecal morphine administered during neuraxial anesthesia for postoperative analgesia following cesarean delivery.
Sponsors & Collaborators
-
Clinica Alemana de Santiago
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-21
- Primary Completion
- 2026-12-31
- Completion
- 2027-03-31
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