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Study on Pain Relief and Safety of Low-Dose Intrathecal Morphine for Women Undergoing Planned Caesarean Section

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on understanding the effectiveness and safety of using a low dose of morphine hydrochloride for managing pain after a planned caesarean section, which is a surgical procedure to deliver a baby. The study will compare the effects of adding a small amount of morphine to the usual pain management methods against a placebo. The goal is to see if this approach can help reduce pain and ensure safety for both the mother and the newborn.

Participants in the study will receive either the low-dose morphine or a placebo during their caesarean section, which is performed under spinal anesthesia. The study will monitor the level of pain when moving from lying down to sitting up within the first 24 hours after surgery. It will also look at the safety of both the mother and the baby, including any breathing issues, severe nausea or vomiting, and the need for hospital admission within a week after leaving the hospital.

Additionally, the study will track the amount of opioid medication used within the first 24 hours, any side effects related to morphine such as nausea or dizziness, and the overall recovery experience of the mother. The satisfaction with pain management and the success of breastfeeding after 30 days will also be evaluated. The trial aims to provide valuable insights into improving pain management for mothers undergoing a caesarean section.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, ensure that you meet the following criteria: you are 18 years or older, have a singleton pregnancy, and are scheduled for an elective caesarean section under spinal anesthesia. Written informed consent is required.

  2. Step 2

    Receiving the medication

    During the procedure, you will receive a low dose of intrathecal morphine (80 micrograms) as part of the trial. This is administered directly into the spinal fluid to help manage pain after the surgery.

  3. Step 3

    Postoperative monitoring

    After the caesarean section, your level of pain will be assessed when moving from a lying to a sitting position within the first 24 hours. This helps evaluate the effectiveness of the pain management.

    Your safety and the safety of your newborn will be monitored. This includes checking for any breathing difficulties, severe nausea or vomiting, and ensuring that neither you nor your newborn require hospital admission within 48 hours.

  4. Step 4

    Monitoring for side effects

    Within the first 24 hours, any side effects related to morphine, such as nausea, vomiting, dizziness, itching, or difficulty urinating, will be monitored.

  5. Step 5

    Pain management evaluation

    Your satisfaction with the pain management during the first 24 hours will be assessed. This helps understand how effective the treatment is from your perspective.

  6. Step 6

    Follow-up

    A follow-up will occur to check if breastfeeding has been successfully established by 30 days after the procedure.

Who can join the trial?

5 criteria

  • Patients must be 18 years or older.
  • Must have a singleton pregnancy, which means carrying only one baby.
  • Scheduled for an elective caesarean section, meaning a planned C-section, which is a surgical procedure to deliver the baby.
  • The procedure must be performed under spinal anaesthesia, which is a type of pain relief used during surgery that numbs the lower part of the body.
  • Must provide written informed consent, which means agreeing to participate in the study after being fully informed about it.

Who cannot join the trial?

5 criteria

  • Patients who are not undergoing an elective caesarean section (a planned surgical procedure to deliver a baby).
  • Patients who do not experience acute postoperative pain (pain that occurs after surgery).
  • Patients who are not within the specified age range for the study.
  • Patients who are not female, as the study is only for female participants.
  • Patients who belong to a vulnerable population that the study does not include.
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Investigated drugs

Intrathecal Morphine is a type of pain relief medication used in this trial. It is administered directly into the spinal fluid to help manage pain after a planned caesarean section. The goal of using this medication is to provide effective pain relief while minimizing the need for other pain medications that might have more side effects. This approach is part of a broader pain management plan to ensure comfort and safety for both the mother and the newborn.

What is already known about the treatment

Intrathecal Morphine – This medication is administered through an injection into the spinal fluid, a method known as intrathecal administration. It is currently being studied in clinical trials for its effectiveness and safety in managing acute postoperative pain following a planned caesarean section. The main therapeutic use of intrathecal morphine in this context is to provide pain relief after surgery. At the molecular level, morphine works by binding to specific receptors in the brain and spinal cord, which helps to block the sensation of pain. It is classified pharmacologically as an opioid analgesic, which means it is a type of pain reliever that works on the nervous system.

Investigated diseases

Acute Postoperative Pain – Acute postoperative pain is a type of pain that occurs after surgical procedures, such as a caesarean section. It typically begins immediately after surgery and can last for a few days. The pain is usually sharp and intense, often localized to the area of the surgery. It can affect a patient's ability to move, such as transitioning from a lying to a sitting position. The intensity of the pain can vary depending on the individual and the type of surgery performed. Managing this pain is crucial for recovery and overall comfort.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518678-16-00Estimated enrolment1 312 patientsSponsorRegion Sjaelland

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