Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery

Pregnant Women Clinical Trial

Official title:

Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery : a Dose-finding Study Bases on the Continual Reassessment Method (CRM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03036384
• Other study ID #: NB076201627436
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: November 2016

Study information

• Verified date: April 2020
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hyperbaric bupivacaine 0.5% associated with opioids is the local anesthetic the most commonly used for spinal injection in cesarean section. Nevertheless, its use often results in a long duration of motor nerve block and a haemodynamical instability. Recently developped, the Prilocaine, with its new 2% hyperbaric formulation, seems to offer a good alternative for hyperbaric bupivicaine. A first study has determined the ED95 of hyperbaric prilocaine 2% for intrathecal anesthesia in scheduled cesarean delivery. As opioid adjuvants potentiate the effect of the local anesthetics while decreasing their dose-related side effects, the aim of this study is to determine the ED95 of hyperbaric prilocaine 2% with sufentanyl for scheduled cesarean delivery under spinal anesthesia,by using the Continual Reassessment Method (CRM)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• 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 155 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:
• HB Prilocaine 2% (varying dose)
Varying dose of hyperbaric (HB) prilocaine 2% according to sensitive response of previous subjects. The dose of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl
• HB Prilocaine 2%
The dose of 45mg of hyperbaric (HB) prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl
• Sufentanil
2.5µg sufentanyl
• Morphine
100 µg Morphine

Locations

Country	Name	City	State
Belgium	University Hospital Saint-Pierre, Université Libre de Bruxelles (ULB)	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	Sensitive Block Duration	Level of Sensory block assessed as loss of sensation to cold, every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, thereafter, once 30 minutes until total regression of sensory block (T12-S1).	Until complete release of sensory block (T12-S1) (average 4 hours)
Secondary	Sensitive Block at End of Surgery	Level of Sensory block assessed as loss of sensation to cold, every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, thereafter, once 30 minutes until total regression of sensory block (T12-S1). For this study, dermatome levels are depicted on a scale ranging from 1 to 18. (1 to 12 = T1-T12 thoracic levels; 13 to 17 = L1-L5 lumbar levels; 18 = S1 sacral level)	Until complete release of sensory block (T12-S1) (average 4 hours)
Secondary	Motor Block Duration	Bromage scale (1 = no motor block; 2 = hip blocked; 3 = hip and knee blocked; and 4 = hip, knee, and ankle blocked) was used to evaluate the motor block every 15 minutes after spinal anaesthesia (T0) and until the end of surgery. Duration was defined from the time of the spinal injection until Bromage scale = 1.	Until complete release of motor block (Bromage scale = 1; average 4 hours)
Secondary	Bromage Motor Block Level at End of Surgery	Bromage scale (1 = no motor block; 2 = hip blocked; 3 = hip and knee blocked; and 4 = hip, knee, and ankle blocked) was used to evaluate the motor block every 15 min after spinal anaesthesia (T0) and until the end of surgery.	Until complete release of motor block (average 4 hours)
Secondary	Newborn Apgar Score	Newborn Apgar score assessed at 1, 5, 10 minutes after baby extraction. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from 0 to 2, then summing up the five values thus obtained. The overall resulting score ranges from 0 to 10 ( 0-3 : severely depressed, 4-6 : Moderately depressed and 7-10 : Excellent condition).; The five criteria are summarized using words chosen to form an abbreviation (Appearance, Pulse, Grimace, Activity, Respiration).	up to 10 minutes after baby extraction
Secondary	Newborn Methemoglobinemia (MetHb)	Newborn Methemoglobinemia (MetHb) will be assessed at delivery by cordal blood sample, as a routine control, and expressed as a percentage of total hemoglobinemia.	average 1 hour
Secondary	Number of Participants Needing Vasopressors	Arterial blood pressure will be measured at every 2.5 minute during surgery, then at every 20 minutes in the PACU (Post Anesthesia Care Unit). Vasopressors were given for patients with low blood pressure.; A low blood pressure is defined 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	Number of Participants With Transient Neurologic Symptoms (TNS)	TNS are defined as pain and/or dysesthesia occurred after complete release of sensory block at the gluteal level, at the thighs and at the legs. At Day 0, Day 1, Day 3 and Day 5	up to 5 Days
Secondary	Number of Participants With Nausea or Vomiting	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	Number of Participants With 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	Number of Participants With Urinary Retention	All parturients will be questioned for urinary retention (yes or no)	Up to 24 hours after surgery
Secondary	Number of Participants With Dizziness	All parturients will be questioned for dizziness (yes or no)	Up to 24 hours after surgery
Secondary	Number of Satisfied Participants	Maternal satisfaction (yes or no) will be assessed 1 hour after surgery in the PACU (Post Anesthesia Care Unit)	up to 1 hour after surgery