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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03607916
Other study ID # B076201524085
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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