Determination of the Optimal Dose of Intrathecal Morphine for Postoperative Analgesia After Cesarean Section Using the Up-and-Down Sequential Allocation Method

What this Trial Is About

Researchers are evaluating the optimal dose of spinal morphine combined with a fixed dose of fentanyl and variable doses of ropivacaine for pain relief after cesarean sections in healthy full-term women. This non-randomized, double-blind study aims to find the dose that provides adequate pain control (pain score under 3 out of 10) for at least 12 hours post-surgery. The study addresses the problem that many women experience moderate to severe pain after cesarean delivery, which can affect their well-being and newborn care, and that current pain treatments may be ineffective or cause side effects. Participants receive spinal anesthesia using a fine needle to inject a mixture containing 15 micrograms of fentanyl, a dose of ropivacaine based on body measurements, and a morphine dose adjusted according to a sequential method. The morphine dose is increased or decreased based on the previous participant's pain relief success, starting at 100 micrograms. The maximum morphine dose allowed is 300 micrograms. After surgery, all women receive additional pain medications like paracetamol and NSAIDs as part of a multimodal pain management plan. During the study, researchers collect medical and obstetric history, monitor the duration of sensory and motor blocks during and after surgery, and record pain scores at several time points up to 24 hours after the spinal injection. They also track side effects, newborn Apgar scores, maternal satisfaction, and any complications linked to anesthesia. The main outcome is the proportion of participants achieving effective pain relief within 12 hours. The study may include 20 to 40 participants to determine the best dose for clinical use.

Determining the Optimal Dose of Intrathecal Morphine for Post-Cesarean Analgesia