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

NCT03936790 | Enrolling By Invitation

• 1 other identifier: EBD866
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cesarean section; combined spinal epidural anaesthesia; tall parturients; ropivacaine ED50 and MLAD

Outcome Measures

Primary Outcomes (2)

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

  Median Effective Dose (ED50) of spinally administered ropivacaine (mg).

  Two to three hours

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

  Minimum Local Analgesic Dose (MLAD) of spinally administered ropivacaine (mg).

  Two to three hours

Study Arms (1)

Ropi_dosing

OTHER

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).

Other: Ropivacaine; Other: Fentanyl

Interventions

Ropivacaine OTHER

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.

Ropi_dosing

Fentanyl OTHER

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

Ropi_dosing

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Paraskevi Matsota: lead

Study Sites (1)

2nd Department of Anesthesiology, Attikon University Hospital

Athens, Attica, 12462, Greece

Location

Related Publications (8)

• Khaw KS, Ngan Kee WD, Wong EL, Liu JY, Chung R. Spinal ropivacaine for cesarean section: a dose-finding study. Anesthesiology. 2001 Dec;95(6):1346-50. doi: 10.1097/00000542-200112000-00011.

  PMID: 11748390 BACKGROUND

• Siddiqui KM, Ali MA, Ullah H. Comparison of spinal anesthesia dosage based on height and weight versus height alone in patients undergoing elective cesarean section. Korean J Anesthesiol. 2016 Apr;69(2):143-8. doi: 10.4097/kjae.2016.69.2.143. Epub 2016 Mar 30.

  PMID: 27066205 BACKGROUND

• Harten JM, Boyne I, Hannah P, Varveris D, Brown A. Effects of a height and weight adjusted dose of local anaesthetic for spinal anaesthesia for elective Caesarean section. Anaesthesia. 2005 Apr;60(4):348-53. doi: 10.1111/j.1365-2044.2005.04113.x.

  PMID: 15766337 BACKGROUND

• Pace NL, Stylianou MP. Advances in and limitations of up-and-down methodology: a precis of clinical use, study design, and dose estimation in anesthesia research. Anesthesiology. 2007 Jul;107(1):144-52. doi: 10.1097/01.anes.0000267514.42592.2a.

  PMID: 17585226 BACKGROUND

• Stroumpoulis K, Stamatakis E, Koutroumanis P, Loukeri A, Valsamidis D. Pencil-point needle bevel direction influences ED50 of isobaric ropivacaine with fentanyl in spinal anesthesia for cesarean delivery: a prospective, double-blind sequential allocation study. Int J Obstet Anesth. 2015 Aug;24(3):225-9. doi: 10.1016/j.ijoa.2015.03.005. Epub 2015 Mar 16.

  PMID: 25936784 BACKGROUND

• Parpaglioni R, Frigo MG, Lemma A, Sebastiani M, Barbati G, Celleno D. Minimum local anaesthetic dose (MLAD) of intrathecal levobupivacaine and ropivacaine for Caesarean section. Anaesthesia. 2006 Feb;61(2):110-5. doi: 10.1111/j.1365-2044.2005.04380.x.

  PMID: 16430561 BACKGROUND

• Geng ZY, Wang DX, Wu XM. Minimum effective local anesthetic dose of intrathecal hyperbaric ropivacaine and bupivacaine for cesarean section. Chin Med J (Engl). 2011 Feb;124(4):509-13.

  PMID: 21362272 BACKGROUND

• Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.

  PMID: 29090733 BACKGROUND

MeSH Terms

Interventions

Ropivacaine; Fentanyl

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Paraskevi Matsota, MD, PhD

  Associate Professor of Anaesthesiology, Second University Clinic of Anaesthesiology, Faculty of Medicine, University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Two anaesthetists are required to conduct the study: a study supervisor who sets the dose of the local anaesthetic for the next participant according to the sequential distribution algorithm and performs the technique and an anaesthetist responsible for recording the study parameters and for the clinical management of the parturient, blinded to the administered dose.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology, 2nd Department of Anaesthesiology, School of Medicine, University of Athens, "Attikon" Hospital, Athens, Greece.

Model Details: The sequential distribution methodology (up-down sequential allocation)

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 3, 2019
• Study Start: June 2, 2019
• Primary Completion: October 20, 2024
• Study Completion: November 1, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

GR (1)