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

ConditionCesarean Section Pain
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Methadone 0.15 mg/kg

    Drug

    Subcutaneous methadone administered for postoperative analgesia following cesarean delivery under neuraxial anesthesia.

  • morphine

    Drug

    Intrathecal morphine administered during neuraxial anesthesia for postoperative analgesia following cesarean delivery.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Subcutaneous methadoneExperimental treatment 1 intervention
Group B: Intrathecal morphineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quality of Recovery-10 (QoR-10) score at 24 hours

cesarean delivery. The QoR-10 is a validated patient-reported outcome measure ranging from 0 to 100, with higher scores indicating better recovery. The study is designed to assess noninferiority of subcutaneous methadone compared to intrathecal morphine using a predefined noninferiority margin of 8 points.

Time frame
24 hours

Secondary outcomes

1

Postoperative pain intensity

Pain intensity measured using a numerical rating scale (0-10) at rest and during movement.

Time frame
Up to 24 hours after surgery
2

Opioid consumption

Total opioid consumtion within the first 24 hours after cesarean section, converted to morphine oral equivalents

Time frame
Up to 24 hours after surgery
3

adverse effects

incidence of nausea, vomiting, pruritus, somnolence, respiratory deppresion within 24 hours

Time frame
24 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinica Alemana de Santiago

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: