Clinical trial

Intrathecal Use of Chloroprocaine 1% and Ropivacaine 0,75% During Elective Cesarean Section. A Comparative Study

Name

434/06-06-2022

Description

This will be a prospective randomized study, aiming at comparing an intrathecal fixed dose of chloroprocaine 1% versus an intrathecal fixed dose of ropivacaine 0.75% in elective cesarean sections

Trial arms

Trial start

2024-01-10

Estimated PCD

2026-01-10

Trial end

2026-01-10

Status

Recruiting

Treatment

Chloroprocaine 1% Injectable Solution

• in parturients allocated to the chloroprocaine group, a fixed dose of chloroprocaine 1% will be administered intrathecally

Arms:

chloroprocaine group

Ropivacaine 0.75% Injectable Solution

• in parturients allocated to the ropivacaine group, a fixed dose of ropivacaine 0.75% will be administered intrathecally

Arms:

ropivacaine group

Size

Primary endpoint

Time from spinal anesthesia to T10 block (min)

intraoperative

Time from spinal anesthesia to T4 block (min)

intraoperative

Time of spinal anesthesia to Bromage =3

intraoperative

level of sensory block every 3 min

intraoperative

level of sensory block every 15 min

intraoperative

highest level of sensory block

intraoperative

time from spinal anesthesia to highest level of sensory block

intraoperative

duration of sensory block

intraoperative

pain at surgical incision

intraoperative

pain at neonatal delivery

intraoperative

pain at peritoneal manipulation

intraoperative

pain at Post Anesthesia Care Unit (PACU) admission

1 hour postoperatively

pain at Post Anesthesia Care Unit (PACU) discharge

1 hour postoperatively

need for rescue analgesia intraoperatively

intraoperative

Bromage scale every 3 min after spinal anesthesia

intraoperative

Bromage scale every 15 min

intraoperative

duration of motor block

1 hour postoperatively

duration of staying in PACU

2 hours postoperatively

Eligibility criteria

Inclusion Criteria: * adult parturients, American Society of Anesthesiologists (ASA) I-II, * singleton gestation\>37 weeks * elective cesarean section Exclusion Criteria: * American Society of Anesthesiologists (ASA) \> III * age \< 18 years * singleton gestation \<37 weeks * Body Mass Index (BMI) \>40 kg/m2 * Body weight \<50 kg * Body weight\>100 kg * height\<150 cm * height\>180 cm * multiple gestation * emergency delivery * fetal abnormality * fetal distress * pregnancy-induced pathology such as preeclampsia, eclampsia, premature labor, placental abnormalities * pregnancy- induced diseases such as hepatic failure, pseudocholinesterase deficiency, neuromuscular diseases * lack of informed consent * contraindication for regional anesthesia such as thrombocytopenia, coagulation abnormalities, allergy to local anesthetics

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2024-04-19

1 organization

2 products

2 indications

Organization

Aretaieion University Hospital

Product

Indication

Indication

Product