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Study Comparing Intrathecal Morphine and TAP Block with Ropivacaine and Clonidine for Pain Relief in Patients Undergoing Elective Cesarean Section

Registered drugNo placebo
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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 managing pain after a planned cesarean section, which is a surgical procedure to deliver a baby through incisions in the abdomen and uterus. The study compares two different pain management methods for women undergoing this procedure with spinal anesthesia. One method involves using a low dose of morphine, a strong pain reliever, injected into the spinal fluid. The other method uses a combination of two medications, ropivacaine and clonidine, administered through a technique called a TAP Block, which numbs the abdominal area.

The purpose of the study is to determine which method is more effective in reducing pain after surgery. Participants will receive either the morphine injection or the TAP Block with ropivacaine and clonidine. The study will monitor the level of pain experienced by participants at various times after the surgery, using a tool called the Visual Analogue Scale (VAS), which helps measure pain intensity.

The trial will take place over a short period, with participants being observed for 24 hours following their cesarean section. This study aims to provide valuable information on the best approach to manage pain for women undergoing this common surgical procedure, ensuring they have a more comfortable recovery experience.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Participation begins after meeting the criteria: planned for an elective cesarean section, scheduled for spinal anesthesia, gestational age over 34 weeks, age 18 years or above, and the ability to read and understand the information sheet and sign the consent form.

  2. Step 2

    Preparation for cesarean section

    Preparation involves receiving spinal anesthesia as part of the procedure for the cesarean section.

  3. Step 3

    Administration of medications

    The trial involves two different approaches for pain management after the cesarean section.

    One group receives intrathecal morphine as an adjuvant. This involves injecting morphine hydrochloride trihydrate into the spinal fluid to help manage pain.

    The other group receives a TAP Block using ropivacaine and clonidine. This involves injecting these medications around the nerves in the abdominal wall to block pain.

  4. Step 4

    Postoperative pain assessment

    Pain levels are assessed using a Visual Analogue Scale (VAS) at various times: 12 AM, 6 PM, 00 AM, and 24 hours after the spinal anesthesia.

    The primary goal is to determine how often the pain score is 6 or more at rest during these evaluations.

  5. Step 5

    Completion of trial participation

    Participation in the trial concludes after the final pain assessment at 24 hours post-anesthesia.

Who can join the trial?

5 criteria

  • Planned for an **elective cesarean section**: This means you are scheduled to have a C-section that is planned in advance, not an emergency one.
  • Scheduled for **spinal anesthesia**: This is a type of anesthesia where medicine is injected into your back to numb the lower part of your body during surgery.
  • **Gestational age** > 34 weeks: Your pregnancy should be more than 34 weeks along.
  • Age 18 years or above: You must be at least 18 years old.
  • Ability to read and understand the information sheet and to sign and date the consent form: You should be able to read and understand the details about the study and agree to participate by signing a form.

Who cannot join the trial?

4 criteria

  • Only women can participate in this study. Men are not eligible.
  • Participants must be undergoing a planned **cesarean section**. This means a scheduled surgery to deliver a baby through an incision in the mother's abdomen and uterus.
  • Participants must be within a specific age range, which is not specified here, but typically means they must be adults.
  • Participants should not be part of any vulnerable population, which generally refers to groups that might need special protection or care.
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Investigated drugs

  • Morphine

    is used in this trial as an intrathecal adjuvant. It is administered directly into the spinal fluid to help manage pain after a cesarean section. The goal is to see if it provides better pain relief compared to other methods.

  • Ropivacaine

    is used in this trial as part of a TAP (Transversus Abdominis Plane) block. It is a local anesthetic that helps numb the area around the abdomen to reduce pain after surgery.

  • Clonidine

    is also used in the TAP block along with ropivacaine. It is added to enhance the pain-relieving effects of the block, helping to manage postoperative pain more effectively.

What is already known about the treatment

  • Morphine

    This medication is administered intrathecally, meaning it is injected into the spinal canal. It is currently being studied in clinical trials for its effectiveness in managing pain after cesarean sections performed under neuraxial anesthesia. Morphine is primarily used for pain relief. It works by binding to opioid receptors in the brain and spinal cord, reducing the perception of pain. Morphine is classified as an opioid analgesic.

  • Ropivacaine

    This medication is administered through a TAP block, which involves injecting it into the abdominal wall to numb the area. It is being evaluated in clinical trials for its role in pain management after cesarean sections. Ropivacaine is used to provide local anesthesia and works by blocking nerve signals in the body. It is classified as a local anesthetic.

  • Clonidine

    This medication is also administered via a TAP block alongside ropivacaine. It is being studied for its potential to enhance pain relief after cesarean sections. Clonidine is used to manage pain and works by stimulating alpha-2 adrenergic receptors, which can help reduce pain signals. It is classified as an alpha-2 adrenergic agonist.

Investigated diseases

Cesarean Section – A cesarean section, often referred to as a C-section, is a surgical procedure used to deliver a baby through incisions in the abdomen and uterus. It is typically performed when a vaginal delivery would put the baby or mother at risk. The procedure involves making an incision in the mother's abdominal wall and another in the uterus to deliver the baby. Recovery from a C-section generally involves a hospital stay and a period of rest at home. The healing process includes managing postoperative pain and monitoring for any signs of infection. Over time, the incisions heal, and the mother gradually returns to normal activities.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513150-29-00Protocol codeThe MIRAGE trialEstimated enrolment100 patientsSponsorIRCCS Istituto Giannina Gaslini

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