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.

2024-513150-29-00 Protocol The MIRAGE trial Therapeutic use (Phase IV) Ongoing, recruiting

Start 19 Mar 2026 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol The MIRAGE trial

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 100
Countries 1
Sites 1

cesarean section

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)

Key facts

Sponsor
IRCCS Istituto Giannina Gaslini
Participant type
Patients
Age range
18-64 years
Gender
Female
Therapeutic area
Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Trial duration
19 Mar 2026 → ongoing
Decision date (initial)
2024-12-19
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2024-513150-29-00
WHO UTN
U1111-1309-5387
ClinicalTrials.gov
NCT07377630

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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)

Conditions and MedDRA coding

cesarean section

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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

Exclusion criteria 11

  1. American Society of Anesthesiologists (ASA) classification >2
  2. Body Mass Index (BMI) ≥ 40 kg/m2
  3. Weight < 50 kg
  4. Height < 150 cm or ≥ 180 cm
  5. Complicated Pregnancy (abnormal placentation, preeclampsia or others)
  6. Women with opioid use disorder
  7. Contraindication to spinal anesthesia (clotting disorder, local infection, spinal malformation, elevated intracranial pressure)
  8. Contraindication to TAP block (skin infection, abdominal wall muscle defects)
  9. Allergy/contraindication to any medication used in the study
  10. Previous median abdominal incision
  11. Emergency or unplanned cesarean section

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The primary endpoint of this trial is the determination of how many times somatic VAS 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 CS is performed after 12 AM) and at 24 hours from the spinal anesthesia

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Morfina cloridrato S.A.L.F. 10 mg/ml soluzione iniettabile

PRD1901043 · Product

Active substance
Morphine Hydrochloride Trihydrate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRATHECAL
Max daily dose
150 µg microgram(s)
Max total dose
150 µg microgram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
N02AA01 — MORPHINE
Marketing authorisation
030677013
MA holder
S.A.L.F. SPA LABORATORIO FARMACOLOGICO
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 2

CATAPRESAN 150 microgrammi/ml soluzione iniettabile

PRD8827508 · Product

Active substance
Clonidine Hydrochloride
Substance synonyms
N-(2,6-DICHLOROPHENYL)-4,5-DIHYDRO-1H-IMIDAZOL-2-AMINE HYDROCHLORIDE
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
PERINEURAL USE
Max daily dose
150 µg microgram(s)
Max total dose
150 µg microgram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
C02AC01 — CLONIDINE
Marketing authorisation
021502036
MA holder
GLENWOOD GMBH
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

ROPIVACAINA CLORIDRATO BIOINDUSTRIA L.I.M. 10 mg/ml soluzione iniettabile

PRD437355 · Product

Active substance
Ropivacaine Hydrochloride
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
PERINEURAL USE
Max daily dose
50 mg milligram(s)
Max total dose
50 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
N01BB09 — ROPIVACAINE
Marketing authorisation
039409089
MA holder
BIOINDUSTRIA LIM LABORATORIO ITALIANO MEDICINALI SPA
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

IRCCS Istituto Giannina Gaslini

8 Total trials 4 Recruiting 2 Ended
Academic / Non-commercial
Sponsor organisation
IRCCS Istituto Giannina Gaslini
Address
Via Gerolamo Gaslini 5
City
Genoa
Postcode
16147
Country
Italy

Scientific contact point

Organisation
IRCCS Istituto Giannina Gaslini
Contact name
Gabriele De Tonetti

Public contact point

Organisation
IRCCS Istituto Giannina Gaslini
Contact name
Gabriele De Tonetti

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Italy Ongoing, recruiting 100 1
Rest of world — 0 —

Investigational sites

Italy

1 site · Ongoing, recruiting
IRCCS Istituto Giannina Gaslini
U.O.S.D. Anestesia e analgesia ostetrica e ginecologica, Via Gerolamo Gaslini 5, 16147, Genoa

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Italy 2026-03-19 2026-03-19

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2024-513150-29-00 1
Protocol (for publication) D4_Patient facing documents_CRF 1
Protocol (for publication) D4_Patient facing documents_Questionario ObsQoR-11 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Subject information and informed consent form (for publication) L1_Letter to general practitioner 1
Subject information and informed consent form (for publication) L1_SIS and ICF adult 1
Subject information and informed consent form (for publication) L1_SIS and ICF adult_Privacy 1
Subject information and informed consent form (for publication) L1_SIS and ICF parents newborn 1
Subject information and informed consent form (for publication) L1_SIS and ICF parents newborn_Privacy 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Clonidina_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Morfina_ITA 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_ITA 2024-513150-29-00 1

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-09-04 Italy Acceptable
2024-12-13
 2024-12-19
2 SUBSTANTIAL MODIFICATION SM-1 2024-12-31 Italy Acceptable 2025-04-01
3 SUBSTANTIAL MODIFICATION SM-2 2026-03-25 Italy Acceptable
2026-05-08
 2026-05-11