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

NCT07377630 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: EU CT 2024-513150-29-00
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pregnancy; Cesarean Section; Neuroaxial Analgesia Procedures

Keywords

cesarean section; neuraxial anesthesia; TAP block; morphine

Outcome Measures

Primary Outcomes (1)

• The primary object is to determine if, in elective cesarean section performed under neuraxial anesthesia, low dose morphine as intrathecal adjuvant is superior to TAP Block using ropivacaine and clonidine in terms of postoperative pain

  The primary endpoint of this trial is the determination of how many times somatic Visual Analogue Scale (or VAS, from worst 0 to best 10) at rest is 6 or more in the different evaluations at 12 AM, 6 PM, 00 AM (or at 6 PM, 00 AM and 6 AM if the cesarean section is performed after 12 AM) and at 24 hours from the spinal anesthesia.

  From enrollment to 24 hours after spinal anesthesia

Secondary Outcomes (6)

• Evaluation of somatic pain with movement

  From enrollment to 24 hours after spinal anesthesia

• Evaluation of visceral pain at rest and on movement

  From enrollment to 24 hours after spinal anesthesia

• Evaluation of rescue dose therapy consumption in mg

  From enrollment to 24 hours after spinal anesthesia

• Incidence of adverse events

  From enrollment to 24 hours after spinal anesthesia

• Evaluate the quality of recovery after surgery for cesarean delivery

  From enrollment to 24 hours after spinal anesthesia

Study Arms (2)

Intrathecal morphine as adjuvant (ITM group)

EXPERIMENTAL

All patients will undergo spinal anesthesia at the L3 to L4 or L4 to L5 interspace with hyperbaric bupivacaine 0.5% (10 mg) and 3 μg of sufentanil, Intrathecal morphine as adjuvant (ITM) group adds morphine 30 μg.

Drug: Intrathecal Morphine

TAP block with ropivacaine and clonidine (TB)

ACTIVE COMPARATOR

At the end of surgery, in the TB group a bilateral ultrasound-guided Transabdominal Plane Block (TAP) block is performed with 20 ml of ropivacaine 0.25% and 75 μg of clonidine each site using a non-Insulated Echogenic Needle 22 Gauge (80 mm). The TAP block will be performed behind the operating drapes so the patient remains blind to the study arm.

Drug: TAP Block

Interventions

Intrathecal Morphine DRUG

The anesthetist in charge performs spinal anesthesia using a 25-gauge pencil point needle in the sitting position at the L3 to L4 or L4 to L5 interspace. After skin disinfection with 2% alcoholic chlorhexidine solution and skin anesthesia with 2 ml of lidocaine 2%, all patients receive spinal anesthesia with a solution of 2 ml hyper-baric bupivacaine 0.5% (10 mg) and 3 μg of sufentanil while, ITM group adds morphine 30 μg. The patient is not informed about the drugs used in spinal anesthesia.

Intrathecal morphine as adjuvant (ITM group)

TAP Block DRUG

At the end of surgery, in the TB group a bilateral Transabdominal Plane Block (TAP) block is performed. The anesthetist prepares two sy-ringes with 20 ml each with ropivacaine 0.25% with 75 μg of clonidine. Upon identifying the TAP compart-ment in the lateral abdominal wall (in the midaxillary line between the bony prominences of the subcostal margin and the iliac crest) with the linear high-frequency ultrasound probe, we penetrate the skin with the block needle using an in-plane technique. Upon entering the plane between the internal oblique and the transversus abdominis muscles, and after negative aspiration of blood, the local anesthetic is slowly injected. The TAP compartment begins to separate, hydrodissect, or "unzip" as the local anesthetic is injected, pushing the transversus abdominis muscle down. An injection of 20 ml of the prepared solution is injected for each side. The TAP block is performed behind the operating drape.

TAP block with ropivacaine and clonidine (TB)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Istituto Giannina Gaslini: lead

Study Sites (1)

Istituto Giannina Gaslini

Genova, GE, 16147, Italy

Location

Central Study Contacts

Gabriele G De Tonetti

CONTACT

0039 3387857400; gabrieledetonetti@gaslini.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: January 30, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 2, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)