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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Odense University Hospital Odense Denmark
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Region Midtjylland Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Region Sjaelland Holbæk Denmark
Hjkdcc Hlywdyyd Herlev Denmark
Afnbiv Uzmjelndqj Hmwukqzg Aarhus Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
01.06.2025

Trial locations

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.

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 ID:
2024-518678-16-00
NCT ID:
NCT06797973
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

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    Investigated diseases:
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