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.
Verified date | August 2018 |
Source | Centre Hospitalier Universitaire Saint Pierre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Saint-Pierre, Université Libre de Bruxelles | Brussels Capital Region |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Saint Pierre |
Belgium,
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
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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03955263 -
Malaria In Pregnancy in Central India
|
||
Not yet recruiting |
NCT04457947 -
Exploring Aromatherapy Intervention in Acute Care
|
||
Active, not recruiting |
NCT01397318 -
Effects of Modified TaiChi Exercise on Maternal Stress, Fatigue, Sleep Quality, Biomarkers, and Infant Gestational Age and Birthweight
|
N/A | |
Completed |
NCT00639145 -
Elizabeth Glaser Pediatric AIDS Foundation Maternal Events and Pregnancy Outcomes (MEP Project)A Multi-site Protocol
|
||
Not yet recruiting |
NCT00931099 -
Fetal Outcome of Sleep Disordered Breathing During Pregnancy
|
N/A | |
Recruiting |
NCT00751569 -
microRNA Profile in Umbilical Cord Blood NK Cells
|
N/A | |
Completed |
NCT06111716 -
Mindfulness in Childbirth Preparation Education Process
|
N/A | |
Completed |
NCT05729191 -
Evaluation of the Acceptance of the Anti-COVID-19 Vaccine Offer Among Pregnant Women
|
||
Completed |
NCT01687634 -
Home Visiting for Low Income, Pregnant Women
|
N/A | |
Recruiting |
NCT05446571 -
Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir
|
Phase 3 | |
Not yet recruiting |
NCT03651934 -
Verification of Correlation Between Genetic Testing of Nutritional Metabolism and Clinical Biochemical Indicators
|
N/A | |
Active, not recruiting |
NCT06422130 -
Ningbo Maternity-Child Linked Database Study
|
||
Completed |
NCT02904473 -
Goals for Reaching Optimum Wellness (GROWell)
|
N/A | |
Completed |
NCT03538106 -
Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes
|
||
Recruiting |
NCT01246765 -
National Pregnancy Registry for Psychiatric Medications
|
||
Completed |
NCT00553228 -
Pertussis Maternal Immunization Study
|
Phase 2/Phase 3 | |
Recruiting |
NCT05916534 -
We Care About Brooklyn - A Digital Behavioral Intervention to Optimize Engagement in Maternal Healthcare
|
N/A | |
Completed |
NCT04264910 -
CALM Pregnancy: Feasibility of Calm for Pregnant Women
|
N/A | |
Completed |
NCT04494581 -
GriCoVax Study in 4 Maternity Wards in the Ile-de-France Region
|
||
Recruiting |
NCT05349279 -
Qatar PREgnancy Covid-19 OUtcome Study
|