By InvitationNot Applicable

Dose-response Study of Spinally Administered Ropivacaine for Caesarean Section in Tall Parturients

Greece40 participantsStarted 2019-06-02

Plain-language summary

The main goal is to determine the optimum dose of ropivacaine, a local anaesthetic, that provides regional anaesthesia with no or minimum adverse effects (i.e. hypotension) when given spinally in healthy full term tall parturients scheduled to undergo caesarean section under combined spinal / epidural anaesthesia (CSEA). The participants' height threshold is based on a local anthropometric research, which included over 2000 people. According to the above research the investigators calculated the female height distribution and decided to include in the study those distributed in the upper quartile (75th to 99th percentile). The female height distribution of the upper quartile ranges from 167 to 184 cm. Secondary objectives are adverse effects related to the anaesthetic technique (hypotension, discomfort, nausea, vomiting and pruritus), the speed of installation and the duration of the regional block (both sensory and motor), blood gas analysis of the newborn umbilical blood as well as newborn Apgar score and lastly the mothers' degree of satisfaction. This is a prospective non randomized double-blinded trial in which a specific algorithm for the local anaesthetic dose will be adopted (up-down sequential allocation). A written informed consent will be required by all participants. The perioperative management of all participants will follow standard clinical protocols. The dose of ropivacaine for each parturient is determined by the response of the previous participant to a higher or lower dose according to the sequential distribution algorithm (up-down sequential allocation). Specifically, the dose of ropivacaine for each parturient (except for the first) will fluctuate by 0.375 mg depending on the success (decrease by 0.375 mg) or failure (increase by 0.375 mg) of the spinal anaesthesia of the previous parturient enrolled in the study. The local anaesthetic dose of the first participant will be determined by a short pilot study.

Who can participate

Age range20 Years – 40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ASA status I - II (ASA; American Society of Anesthesiologists) * height: 167 to 184 cm * age: 20 to 40 years old * normal single pregnancy * full term pregnancy (\> 37 weeks) * elective caesarean section. Exclusion Criteria: * refusal of the parturient, inability to communicate * obesity (BMI\> 35 Kg/m2) * baseline maternal heart rate less than 60 or above 130 bpm * high risk pregnancy (gestational hypertension, preeclampsia / eclampsia, gestational diabetes, multiple pregnancies) * known or suspected foetal pathology (intrauterine growth retardation, poly- or oligohydramnios) * history of clinically significant cardiovascular, pulmonary, hepatic, renal, neurological, psychiatric or metabolic disease * active labour * history of allergy in amidic anaesthetics or any of the drugs used in the trial * contraindications for regional technique such as coagulation disorders, inflammation of the lumbar region, systemic sepsis * dural puncture.

What they're measuring

ED50 of spinal ropivacaine administered to healthy tall parturients for cesarean delivery.

Timeframe: Two to three hours

MLAD of spinal ropivacaine administered to healthy tall parturients for cesarean delivery.

Timeframe: Two to three hours

Trial details

NCT IDNCT03936790

SponsorParaskevi Matsota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-20