Clinical trial • Not applicable • Other
MORPHINE HYDROCHLORIDE TRIHYDRATE for Cesarean section
Not applicable trial of MORPHINE HYDROCHLORIDE TRIHYDRATE for Cesarean section.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Cesarean section
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 04-09-2024
- First CTIS Authorization Date
- 19-12-2024
Trial design
Randomised, comparator arm: transversus abdominis plane (tap) block using ropivacaina cloridrato bioindustria l.i.m. 10 mg/ml soluzione iniettabile (ropivacaine hydrochloride; perineural use; product record max total dose 50 mg) combined with catapresan 150 microgrammi/ml soluzione iniettabile (clonidine hydrochloride; perineural use; product record max total dose 150 µg). test arm: morfina cloridrato s.a.l.f. 10 mg/ml soluzione iniettabile (morphine hydrochloride trihydrate; intrathecal). (dose schedules not specified in ctis record.)-controlled Not applicable trial in Italy.
- Randomised
- Yes
- Comparator
- Comparator arm: Transversus abdominis plane (TAP) block using ROPIVACAINA CLORIDRATO BIOINDUSTRIA L.I.M. 10 mg/ml soluzione iniettabile (ropivacaine hydrochloride; perineural use; product record max total dose 50 mg) combined with CATAPRESAN 150 microgrammi/ml soluzione iniettabile (clonidine hydrochloride; perineural use; product record max total dose 150 µg). Test arm: Morfina cloridrato S.A.L.F. 10 mg/ml soluzione iniettabile (morphine hydrochloride trihydrate; intrathecal). (Dose schedules not specified in CTIS record.)
- Target Sample Size
- 100
- Trial Duration For Participant
- 1
Eligibility
Recruits 100 Participants are adult women undergoing elective cesarean section (age ≥18). A vulnerable population was not selected in the CTIS record. Informed consent must be provided by the participant who must be able to read and understand the information sheet and sign the consent form. Subject information and ICF documents are provided for adults and for parents of newborns..
- Pregnancy Exclusion
- Complicated Pregnancy (abnormal placentation, preeclampsia or others)
- Vulnerable Population
- Participants are adult women undergoing elective cesarean section (age ≥18). A vulnerable population was not selected in the CTIS record. Informed consent must be provided by the participant who must be able to read and understand the information sheet and sign the consent form. Subject information and ICF documents are provided for adults and for parents of newborns.
Inclusion criteria
- {"criterion_text":"- Planned for elective cesarean section"}
- {"criterion_text":"- Scheduled for spinal anesthesia"}
- {"criterion_text":"- Gestational age > 34 weeks"}
- {"criterion_text":"- Age 18 years or above"}
- {"criterion_text":"- Ability to read and understand the information sheet and to sign and date the consent form"}
Exclusion criteria
- {"criterion_text":"- American Society of Anesthesiologists (ASA) classification >2"}
- {"criterion_text":"- Previous median abdominal incision"}
- {"criterion_text":"- Emergency or unplanned cesarean section"}
- {"criterion_text":"- Body Mass Index (BMI) ≥ 40 kg/m2"}
- {"criterion_text":"- Weight < 50 kg"}
- {"criterion_text":"- Height < 150 cm or ≥ 180 cm"}
- {"criterion_text":"- Complicated Pregnancy (abnormal placentation, preeclampsia or others)"}
- {"criterion_text":"- Women with opioid use disorder"}
- {"criterion_text":"- Contraindication to spinal anesthesia (clotting disorder, local infection, spinal malformation, elevated intracranial pressure)"}
- {"criterion_text":"- Contraindication to TAP block (skin infection, abdominal wall muscle defects)"}
- {"criterion_text":"- Allergy/contraindication to any medication used in the study"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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","definition_or_measurement_approach":"Measured using the Visual Analogue Scale (VAS) at rest; primary endpoint counts the number of times VAS ≥ 6 at the specified post‑spinal anesthesia time points (scheduled assessments at 12h, 18h, 24h depending on timing as specified)."}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 24
- Consent Approach
- Informed consent is provided by the adult participant; inclusion criterion requires ability to read and understand the information sheet and to sign and date the consent form. Subject information and informed consent form documents exist for adults and for parents of newborns (ICF documents listed). Specific languages or remote consent methods are not specified in the CTIS record.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 100
Italy
- Earliest CTIS Part Ii Submission Date
- 20-11-2024
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 537
- Number Of Sites
- 1
- Number Of Participants
- 100
Sites
- Site Name
- IRCCS Istituto Giannina Gaslini
- Department Name
- U.O.S.D. Anestesia e analgesia ostetrica e ginecologica
- Principal Investigator Name
- Gabriele De Tonetti
- Principal Investigator Email
- anestesiaostetricia@gaslini.org
- Contact Person Name
- Gabriele De Tonetti
- Contact Person Email
- anestesiaostetricia@gaslini.org
- Number Of Participants
- 100
Sponsor
Primary sponsor
- Full Name
- IRCCS Istituto Giannina Gaslini
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Italy
Investigational products
- Investigational Product Name
- Morfina cloridrato S.A.L.F. 10 mg/ml soluzione iniettabile
- Active Substance
- MORPHINE HYDROCHLORIDE TRIHYDRATE
- Modality
- Small molecule
- Routes Of Administration
- INTRATHECAL
- Route
- INTRATHECAL
- Authorisation Status
- Authorised
- Maximum Dose
- 150 µg
- Investigational Product Name
- ROPIVACAINA CLORIDRATO BIOINDUSTRIA L.I.M. 10 mg/ml soluzione iniettabile
- Active Substance
- ROPIVACAINE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- PERINEURAL USE
- Route
- PERINEURAL USE
- Authorisation Status
- Authorised
- Maximum Dose
- 50 mg
- Investigational Product Name
- CATAPRESAN 150 microgrammi/ml soluzione iniettabile
- Active Substance
- CLONIDINE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- PERINEURAL USE
- Route
- PERINEURAL USE
- Authorisation Status
- Authorised
- Maximum Dose
- 150 µg
- Combination Treatment
- Yes
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