Authorised Therapeutic use (Phase IV) cesarean section

Intrathecal MoRphine versus TAP Block for AnalGesic management in Elective caesarean section performed under neuraxial anesthesia. A monocentric pilot randomized controlled trial. The MIRAGE trial.

EU CTIS ID: 2024-513150-29-00

What this study is testing

The primary objective of this trial is to determine if, in elective CS performed under neuraxial anesthesia, low dose morphine as intrathecal adjuvant is superior to TAP Block using ropivacaine and clonidine in terms of postoperative somatic pain at rest, assessed with Visual Analogue Scale (VAS)

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Planned for elective cesarean section
  • Scheduled for spinal anesthesia
  • Gestational age > 34 weeks
  • Age 18 years or above
  • Ability to read and understand the information sheet and to sign and date the consent form

You likely can't join if

  • American Society of Anesthesiologists (ASA) classification >2
  • Previous median abdominal incision
  • Emergency or unplanned cesarean section
  • Body Mass Index (BMI) ≥ 40 kg/m2
  • Weight < 50 kg
  • Height < 150 cm or ≥ 180 cm
See the full eligibility criteria
Who can join
  • Planned for elective cesarean section
  • Scheduled for spinal anesthesia
  • Gestational age > 34 weeks
  • Age 18 years or above
  • Ability to read and understand the information sheet and to sign and date the consent form
What rules you out
  • American Society of Anesthesiologists (ASA) classification >2
  • Previous median abdominal incision
  • Emergency or unplanned cesarean section
  • Body Mass Index (BMI) ≥ 40 kg/m2
  • Weight < 50 kg
  • Height < 150 cm or ≥ 180 cm
  • Complicated Pregnancy (abnormal placentation, preeclampsia or others)
  • Women with opioid use disorder
  • Contraindication to spinal anesthesia (clotting disorder, local infection, spinal malformation, elevated intracranial pressure)
  • Contraindication to TAP block (skin infection, abdominal wall muscle defects)
  • Allergy/contraindication to any medication used in the study

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.