Ongoing Clinical Trials for Caesarean Section Pain Management
There are currently 2 ongoing clinical trials exploring different approaches to managing pain after caesarean section surgery. These studies are comparing various medications and techniques to improve comfort and recovery for mothers undergoing this common surgical procedure.
Clinical trial locations
- Denmark
- Italy
Study on Pain Relief and Safety of Low-Dose Intrathecal Morphine for Women Undergoing Planned Caesarean Section
This trial, taking place in Denmark, is investigating whether adding a small dose of morphine to standard pain management can improve comfort after a planned caesarean section.
Who can participate: Women aged 18 years or older who are carrying a single baby and scheduled for a planned caesarean section under spinal anesthesia can join this study. Participants must provide written informed consent after being fully informed about the trial.
Who cannot participate: Women who are not having a planned caesarean section, those outside the specified age range, and those belonging to vulnerable populations that the study does not include are excluded from participation.
What the trial involves: The study focuses on managing acute postoperative pain, which is the sharp, intense pain that occurs immediately after surgery and can last for several days. Participants will receive either a low dose of intrathecal morphine (80 micrograms injected directly into the spinal fluid) or a placebo during their caesarean section. The main goal is to evaluate pain levels when moving from lying down to sitting up within the first 24 hours after surgery.
Researchers will also carefully monitor safety for both mother and baby, including checking for breathing difficulties, severe nausea or vomiting, and whether hospital admission is needed within 48 hours. The trial will track the amount of opioid medication used in the first 24 hours, any side effects such as nausea, dizziness, itching, or difficulty urinating, and overall recovery experience. Additionally, the study will assess satisfaction with pain management and whether breastfeeding has been successfully established by 30 days after the procedure.
Investigational drug: The trial uses intrathecal morphine, which is administered directly into the spinal fluid. Morphine works by binding to specific receptors in the brain and spinal cord to block pain signals. This approach aims to provide effective pain relief while reducing the need for other pain medications that might have more side effects.
Study Comparing Intrathecal Morphine and TAP Block with Ropivacaine and Clonidine for Pain Relief in Patients Undergoing Elective Cesarean Section
This Italian trial is comparing two different methods of pain management after planned caesarean section to determine which approach provides better pain relief.
Who can participate: Women aged 18 years or older who are scheduled for a planned caesarean section under spinal anesthesia and are more than 34 weeks pregnant can join this study. Participants must be able to read and understand the information sheet and sign the consent form.
Who cannot participate: Men are not eligible for this study. Women who are not undergoing a planned caesarean section, those outside the specified age range, and those belonging to vulnerable populations are excluded.
What the trial involves: This study compares two pain management approaches. One group receives intrathecal morphine injected into the spinal fluid, while the other group receives a TAP Block, which involves injecting medications around the nerves in the abdominal wall to block pain. The TAP Block uses a combination of ropivacaine and clonidine.
Pain levels are measured using a Visual Analogue Scale at specific times: 12 hours, 6 hours, immediately after, and 24 hours following the spinal anesthesia. The primary goal is to determine how often the pain score reaches 6 or more at rest during these assessments. This helps researchers understand which method provides more effective pain control during the recovery period.
Investigational drugs: Three medications are being studied in this trial. Morphine is administered intrathecally (into the spinal fluid) and works by binding to opioid receptors in the brain and spinal cord to reduce pain perception. Ropivacaine is a local anesthetic used in the TAP Block that works by blocking nerve signals in the body to numb the abdominal area. Clonidine is also used in the TAP Block alongside ropivacaine to enhance pain relief by stimulating specific receptors that help reduce pain signals.
Summary
Both ongoing trials are exploring ways to improve pain management after planned caesarean section, with studies currently taking place in Denmark and Italy. A common theme is the investigation of intrathecal morphine as a pain relief option, with both trials examining its effectiveness and safety profile. The Danish study specifically focuses on low-dose morphine compared to placebo, while the Italian trial compares morphine to an alternative approach using a TAP Block with ropivacaine and clonidine. These studies reflect ongoing efforts to find the most effective pain management strategies that balance good pain relief with minimal side effects for both mothers and newborns during the recovery period after caesarean section.
