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

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.

Conditions

• Regional Anaesthesia
• Cesarean Section

Interventions

OTHER

Ropivacaine

In case of successful spinal anaesthesia, the dose of spinally administered ropivacaine will decrease by 0.375 mg for the next participant.In case of unsuccessful spinal anaesthesia, the dose of spinally administered ropivacaine will increase by 0.375 mg for the next participant.

OTHER

Fentanyl

A fix dose of fentanyl (15 mcg) will be co-administered spinally to all participants.

Sponsors & Collaborators

• Paraskevi Matsota

  lead OTHER

Principal Investigators

• Paraskevi Matsota, MD, PhD · Associate Professor of Anaesthesiology, Second University Clinic of Anaesthesiology, Faculty of Medicine, University of Athens

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

20 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-06-02

Primary Completion

2024-10-20

Completion

2025-11-30

Countries

• Greece

Study Locations