Estimation of the Effective Dose (ED) 95 of Intrathecal Hyperbaric Prilocaine 2% for Scheduled Cesarean Delivery.

Pregnant Women Clinical Trial

Official title:

Estimation of the Effective Dose (ED) 95 of Intrathecal Hyperbaric Prilocaine 2% for Scheduled Cesarean Delivery : a Dose-finding Study Based on the Continual Reassessment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03607916
• Other study ID #: B076201524085
• Status: Completed
• Phase: Phase 2
• Start date: February 2014
• Est. completion date: August 2014

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prilocaine is a local anesthetic drug which as an intermediate duration of action shorter than bupivacaine 0,5% that is usually used for spinal anesthesia in scheduled cesarean section. No study has yet investigated the use of hyperbaric (HB) prilocaine 2% for intrathecal anesthesia in cesarean section. The aim of this study is to determine the Effective Dose (ED) 95 of hyperbaric (HB) prilocaine 2% by using the Continual Reassessment Method (CRM)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status (ASA) < III

• Age 18-40 year

• Body Weight <100 kg

• Height between 160 and 175 cm

• Gestational age>37 SA

• Elective cesarean delivery

• Singleton pregnancy

• Non complicated pregnancy

• Signed informed consent obtained prior to any study specific assessments and procedures

Exclusion Criteria:

• Twin pregnancy

• History of 2 cesarean section or more

• Diabetes and gestational diabetes

• Placenta praevia

• Congenital foetal abnormality

• Patient in labour

• Membrane rupture

• Known allergy to local anaesthetics

• Disagreement of the patient

• Pregnancy-induced hypertension

• Pre eclampsia and eclampsia

Related Conditions & MeSH terms

• Pregnant Women

Intervention

Drug:
• Hyperbaric prilocaine 2%
Varying dose according to sensitive response of previous subjects. All study doses of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine
• Hyperbaric prilocaine 2%
The dose of 60 mg of Hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine
• Morphine
100µg morphine

Locations

Country	Name	City	State
Belgium	University Hospital Saint-Pierre, Université Libre de Bruxelles	Brussels Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

Camponovo C, Fanelli A, Ghisi D, Cristina D, Fanelli G. A prospective, double-blinded, randomized, clinical trial comparing the efficacy of 40 mg and 60 mg hyperbaric 2% prilocaine versus 60 mg plain 2% prilocaine for intrathecal anesthesia in ambulatory surgery. Anesth Analg. 2010 Aug;111(2):568-72. doi: 10.1213/ANE.0b013e3181e30bb8. Epub 2010 Jun 7. — View Citation

Gupta PK, Chevret S, Zohar S, Hopkins PM. What is the ED95 of prilocaine for femoral nerve block using ultrasound? Br J Anaesth. 2013 May;110(5):831-6. doi: 10.1093/bja/aes503. Epub 2013 Feb 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of anesthesia	The nerve blockade will be considered as success when a bilateral T4 level will reach in 15 minutes after intrathecal injection without additional epidural injection needed within 45 minutes peri-operative ; no pain at the skin incision, no pain during 45 minutes after the skin incision	during surgery (average 1 hour)
Secondary	Level of Sensory block assessed as loss of sensation to pinprick, cold and pressure	Every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, thereafter, once every hour until total regression of sensory block (T12-S1).	Until complete release of sensory block (T12-S1) (average 4 hours)
Secondary	Side-effects (nausea, vomiting,pruritus)	from 15 minutes after spinal anesthesia and every 4 hours for 24 hours (score 0=no symptoms; 1=symptoms with no treatment necessary; 2=symptoms present and treated)	up to 24 hours after surgery
Secondary	Transient neurologic symptoms (TNS)	TNS are defined as pain and/or dysesthesia occured after complete release of sensory block at the gluteal level, at the tights and at the legs. At Day 0, Day 1, day 3 and Day 5	up to 5 Days
Secondary	Pain as assessed by Visual Analogue Scale (VAS)	Pain levels will be determined every 5 minutes during surgery. The Visual Analogue score (scale : 0 = no pain; 10= worst pain imaginable)	during surgery (average 1 hour)
Secondary	Number of participants with low blood pressure	Arterial blood pressure will be measured at every 2.5 minute during the first 15 minutes, then at every 5 minutes until the end of surgery. A blood pressure lower is define as a blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia)	during surgery (average 1 hour)
Secondary	Methemoglobinemia	Methemoglobin level measured in umbilical cord blood of new born at the delivery	at delivery (average 1 hour)