Intrathecal MoRphine Versus Transabdominal Plane Block (TAP) Block for AnalGesic Management in Elective Caesarean Section

Starting soon · Phase 4

Conditions studied: Pregnancy, Cesarean Section, Neuroaxial Analgesia Procedures

In brief

The goal of this randomized controlled clinical trial is to determine if low-dose intrathecal morphine is superior to a Transversus Abdominis Plane (TAP) block with ropivacaine and clonidine for postoperative analgesia in women aged 18 years or older undergoing elective cesarean section under neuraxial anesthesia. The main questions it aims to answer are: * Is intrathecal morphine more effective than TAP block in reducing postoperative somatic pain at rest? * Does intrathecal morphine differ from TAP block in terms of adverse events, pain during mobilization, visceral pain, rescue analgesic use, maternal satisfaction, and newborn wellbeing? Researchers will compare the intrathecal morphine (ITM) group to the TAP block (TB) group to see if ITM provides superior analgesia and improved secondary outcomes. Participants will: * Undergo spinal anesthesia with hyperbaric bupivacaine and sufentanil * add 30 μg intrathecal morphine (only ITM group) * receive bilateral ultrasound-guided TAP block with 20 ml ropivacaine 0.25% and 75 μg clonidine per side (only TB group) * receive standardized postoperative analgesia with paracetamol, ibuprofen, and tramadol as needed * be monitored postoperatively for pain (somatic and visceral, at rest and with movement), adverse events, mobilization, maternal satisfaction, and newborn outcomes at regular intervals for 24 hours This is a single-center, pilot, single-blind trial involving 100 participants (50 per group).

Key facts

Study ID

NCT07377630

Run by

Istituto Giannina Gaslini

People needed

100

Starts

2026-03-01

Expected to finish

2027-03-02

Last updated by the study team

2026-01-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Planned for elective Cesarean Section (CS)
• 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 may not qualify if…

• American Society of Anesthesiologists (ASA) classification >2
• 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 Transabdominal Plane Block (TAP) block (skin infection, abdominal wall muscle defects)
• Allergy/contraindication to any medication used in the study
• Previous median abdominal incision
• Emergency or unplanned CS

Where it is running

• Istituto Giannina Gaslini — Genova, GE, Italy

Full record on ClinicalTrials.gov

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