PregnancyPhase 4MIRAGENCT07377630
Intrathecal MoRphine Versus Transabdominal Plane Block (TAP) Block for AnalGesic Management in Elective Caesarean Section
A Phase 4 study testing Intrathecal Morphine and TAP Block in people with Pregnancy and Cesarean Section, run by Istituto Giannina Gaslini at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Cesarean Section, Neuroaxial Analgesia Procedures
- What is being tested?
- Intrathecal Morphine and TAP Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2026to 2 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Istituto Giannina Gaslini
Genova, GE, 16147
Gabriele G De Tonetti, 0039 3387857400, gabrieledetonetti@gaslini.org
About this study
Official title: Intrathecal MoRphine Versus Transabdominal Plane Block (TAP) Block for AnalGesic Management in Elective Caesarean Section Performed Under Neuraxial Anesthesia. A Monocentric Pilot Randomized Controlled Trial
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:
Read more
- 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).
Read the detailed description
It is a monocentric randomized single-blind controlled pilot trial, wherein the patient and the biostatistics will be unaware about assigned treatment group, whereas the study investigators and site staff will be aware of the treatment group.
The trial consists in two treatment arms:
- Transabdominal Plane Block (TAP) block with ropivacaine and clonidine performed at the end of surgery (this will be performed in the operating room, behind a drape, so that the patient is unaware of the study arm)
- Addition of low doses of morphine to the other drugs administered during the performance of spinal anaesthesia Women aged 18 years and older, with indication for elective caesarean section, gestational age 34 weeks and older, admitted to the Giannina Gaslini Institute will participate in this study.
After an adequate anamnesis, the confirmation of the presence of all the inclusion criteria and the absence of the exclusion criteria and the acquisition of the informed consent, the subjects will be assigned to the treatment arm with a computer-generated random number sequence. The investigator/designated study personnel will administer the treatment as per the randomization codes.
Clinical and instrumental parameters (such as pain, vital signs, the possible occurrence of symptoms such as nausea, vomiting, itching) will then be evaluated during the caesarean section and at 12, 18, 24 hours on the day of the caesarean section (possibly at 6 a.m. on the following day in the case of a caesarean section after 12 noon) and 24 hours after the operation, and the use of analgesics as needed in the case of uncontrolled pain (previously prescribed by the anaesthetist). The baby's well-being will be assessed at birth and, 24 hours after the operation, a questionnaire will be submitted to the patient, to assess her satisfaction.
The study intervention will be performed in the operating room of Departmental Unit of Obstetrics and Gyne-cology of IRCSS Giannina Gaslini Institute. The follow up will be performed in the inpatient ward of the same Departmental Unit.
For the purpose of this trial, the end of study (EOS) is defined as the last visit of last patient.
A total number of 100 participants, a sample size of 50 per group, will be recruited during the study.
- Conditions
- Pregnancy, Cesarean Section, Neuroaxial Analgesia Procedures
- Being tested
- Intrathecal Morphine, TAP Block
- Keywords
- cesarean section, neuraxial anesthesia, TAP block, morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal MorphineDrug
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.
TAP BlockDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: TAP Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 24 hours after spinal anesthesia
Secondary outcomes (6)
Evaluation of somatic pain with movement
STATISTICAL DIFFERENCE OF MEAN AND STANDARD DEVIATION (SD) OF Somatic Pain (with visual analogue scale 0 worst-10 best)
Measured: From enrollment to 24 hours after spinal anesthesia
Evaluation of visceral pain at rest and on movement
STATISTICAL DIFFERENCE OF MEAN AND STANDARD DEVIATION (SD) of Visceral Pain (with visual analogue scale 0 worst-10 best)
Measured: From enrollment to 24 hours after spinal anesthesia
Evaluation of rescue dose therapy consumption in mg
STATISTICAL DIFFERENCE OF MEAN AND STANDARD DEVIATION OF Time to First Rescue Dose (min)
Measured: From enrollment to 24 hours after spinal anesthesia
Incidence of adverse events
Measure the incidence of Nausea (Internal Gaslini scale, 0 best - 4 worst), incidence of pruritus (Internal Gaslini scale, 0 best - 3 worst), incidence of Urinary Retention (occurrence and need for catheterization), incidence of Hypothension (systolic arterial pressure <100 mmHg or <80% of baseline, total mg of ephedrine) and Bradycardia (heart rate <50 bpm)
Measured: From enrollment to 24 hours after spinal anesthesia
Evaluate the quality of recovery after surgery for cesarean delivery
MEAN AND STANDARD DEVIATION OF Obstetric Quality-of-Recovery score ObsQoR-11 (worst 0-best110 pts)
Measured: From enrollment to 24 hours after spinal anesthesia
Incidence of Hypotension
Measurement thorugh systolic arterial pressure <100 mmHg or <80% of baseline, total mg of ephedrine and evaluation of Bradycardia as heart rate <50 bpm
Measured: From enrollment to 24 hours after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion2 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Giannina Gaslini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377630
- Sponsor's protocol ID
- EU CT 2024-513150-29-00
- Acronym
- MIRAGE
- Status last verified
- Jan 2026
- First submitted
- 7 Aug 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal MoRphine Versus Transabdominal Plane Block (TAP) Block for AnalGesic Management in Elective Caesarean Section Performed Under Neuraxial Anesthesia. A Monocentric Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07377630
- Acronym / sponsor ID
- MIRAGE / EU CT 2024-513150-29-00
- Conditions
- Pregnancy, Cesarean Section, Neuroaxial Analgesia Procedures
- Keywords
- cesarean section, neuraxial anesthesia, TAP block, morphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istituto Giannina GasliniUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 2 Mar 2027 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
It is a monocentric randomized single-blind controlled pilot trial, wherein the patient and the biostatistics will be unaware about assigned treatment group, whereas the study investigators and site staff will be aware of the treatment group.
The trial consists in two treatment arms:
- Transabdominal Plane Block (TAP) block with ropivacaine and clonidine performed at the end of surgery (this will be performed in the operating room, behind a drape, so that the patient is unaware of the study arm)
- Addition of low doses of morphine to the other drugs administered during the performance of spinal anaesthesia Women aged 18 years and older, with indication for elective caesarean section, gestational age 34 weeks and older, admitted to the Giannina Gaslini Institute will participate in this study.
After an adequate anamnesis, the confirmation of the presence of all the inclusion criteria and the absence of the exclusion criteria and the acquisition of the informed consent, the subjects will be assigned to the treatment arm with a computer-generated random number sequence. The investigator/designated study personnel will administer the treatment as per the randomization codes.
Clinical and instrumental parameters (such as pain, vital signs, the possible occurrence of symptoms such as nausea, vomiting, itching) will then be evaluated during the caesarean section and at 12, 18, 24 hours on the day of the caesarean section (possibly at 6 a.m. on the following day in the case of a caesarean section after 12 noon) and 24 hours after the operation, and the use of analgesics as needed in the case of uncontrolled pain (previously prescribed by the anaesthetist). The baby's well-being will be assessed at birth and, 24 hours after the operation, a questionnaire will be submitted to the patient, to assess her satisfaction.
The study intervention will be performed in the operating room of Departmental Unit of Obstetrics and Gyne-cology of IRCSS Giannina Gaslini Institute. The follow up will be performed in the inpatient ward of the same Departmental Unit.
For the purpose of this trial, the end of study (EOS) is defined as the last visit of last patient.
A total number of 100 participants, a sample size of 50 per group, will be recruited during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal morphine as adjuvant (ITM group) | Experimental | Drug: Intrathecal MorphineAll 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. |
| TAP block with ropivacaine and clonidine (TB) | Active comparator | Drug: TAP BlockAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal MorphineThe 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. | Drug | Intrathecal morphine as adjuvant (ITM group) |
| TAP BlockAt 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. | Drug | TAP block with ropivacaine and clonidine (TB) |
Primary outcome
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
Time frame: From enrollment to 24 hours after spinal anesthesia
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.
6 secondary outcomes
Evaluation of somatic pain with movement
Time frame: From enrollment to 24 hours after spinal anesthesia
Evaluation of visceral pain at rest and on movement
Time frame: From enrollment to 24 hours after spinal anesthesia
Evaluation of rescue dose therapy consumption in mg
Time frame: From enrollment to 24 hours after spinal anesthesia
Incidence of adverse events
Time frame: From enrollment to 24 hours after spinal anesthesia
Evaluate the quality of recovery after surgery for cesarean delivery
Time frame: From enrollment to 24 hours after spinal anesthesia
Incidence of Hypotension
Time frame: From enrollment to 24 hours after spinal anesthesia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intrathecal Morphine and TAP Block in people with Pregnancy and Cesarean Section, run by Istituto Giannina Gaslini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriele G De Tonetti (0039 3387857400, gabrieledetonetti@gaslini.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From enrollment to 24 hours after spinal anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.