Prilocaine or Bupivacaine for Spinal Anesthesiain Pregnant

Cesarean Clinical Trial

— Césarcaïne  

Official title:

Comparison of the Duration of Motor Block After Spinal Anesthesia for Planned Cesarean Sections: Hyperbaric Prilocaïne Versus Hyperbaric Bupivacaine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03433976
• Other study ID #: UF9859
• Status: Recruiting
• Phase: Phase 2
• Start date: May 7, 2018
• Est. completion date: August 30, 2020

Study information

• Verified date: March 2018
• Source: University Hospital, Montpellier
• Contact: christophe DADURE, MD, PhD
• Phone: 467338256
• Email: c-dadure[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The planned cesarean section is an intervention with a standard operating time of less than 40 minutes in trained teams. Hyperbaric Bupivacaine is the local anesthetic (LA) reference for these operations. But the duration of its motor block is generally greater than 3 hours. The purpose of this study is to show a reduction in motor block time with hyperbaric Prilocaine by at least 30 minutes, which would allow mothers and their children to return to the maternity ward earlier and thus improve the circulation of patients within the maternity's PACU.

Description:

Prospective study, randomized into two parallel groups (Hyperbaric Prilocaïne versus hyperbaric Bupivacaine), double-blind, monocentric (Clinique Saint Roch in Montpellier).

The number of subjects required is 50 patients, 25 per group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 30, 2020
• Est. primary completion date: May 7, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Normal pregnancy

• Scheduled caesarean section

• Non-multiple pregnancy

• Age of patient: 18 years and over

• Height of patient: between 155 and 175 cm

• Affiliated patients or beneficiaries of a Social Security System

• Signature of the patient's consent

Exclusion criteria:

• Patient <18 years

• Pathological pregnancy

• Multiple pregnancy

• Emergency caesarean

• Patients who cannot give informed consent (not French speaking)

• Refusal of the patient

• Contraindications to spinal anesthesia

• Contraindications to Prilocaine

• Contraindications to Bupivacaine

Related Conditions & MeSH terms

• Cesarean

Intervention

Drug:
• spinal anesthesia
spinal anesthesia for planned cesarean sections

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Hopital Saint Roch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of motor block	To compare the duration of motor block after spinal anesthesia with hyperbaric Prilocaïne versus hyperbaric Bupivacaine This evaluation is done every 15 min from the entrance to the recovery room (PACU); the motor block stops being evaluated when the modified bromination score reaches 4	up to 6 hours
Secondary	The upper sensory level	The upper sensory level obtained 15 minutes after the LA injection	15 minutes after the LA injection
Secondary	Hypotensive episodes	Hypotensive episodes	1 day
Secondary	The time between injection and incision	The time between injection and incision	1 day
Secondary	The duration of the intervention	The duration of the intervention	1 day
Secondary	The time to return to the standard maternity ward	The time to return to the standard maternity ward	1 day
Secondary	APGAR score of newborns at birth	APGAR score of newborns at birth. L'APGAR Apgar score is a method to quickly summarize the health of newborn children.; The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form a backronym (Appearance, Pulse, Grimace, Activity, Respiration).; The test is generally done at one and five minutes after birth, and may be repeated later if the score is and remains low. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.	1 day
Secondary	The delay between spinal anesthesia and the first emergency analgesic injection	The delay between spinal anesthesia and the first emergency analgesic injection	1 day
Secondary	Assessment of pain (VAS)	Pain on arrival and departure of PACU and at 24 hours. Pain will be assessedby VAS (Visual Analogue Scale); Patients rate pain on VAS from 0-10, 0 being no pain and 10 being the worst pain imaginable..	1 day
Secondary	The delay between spinal anesthesia and the first injection of second-line analgesia	The delay between spinal anesthesia and the first injection of second-line analgesia : delay between spinal anesthesia ans the need of rescue analgesia	1 day
Secondary	The presence of neuro-sensory disorders within 24 hours postoperatively	The presence of neuro-sensory disorders within 24 hours postoperatively	1 day
Secondary	The presence of post lumbar puncture syndrome	The presence of post lumbar puncture syndrome	1 day
Secondary	score de satisfaction	Patient satisfaction score at 24 hours will be assessed by VAS (Visual Analogue Scale); Patients rate satisfaction on VAS from 0-10, 0 being no satisfaction and 10 being total satisfaction	1 day
Secondary	Statifaction of the Surgeon	The surgeon assessed his satisfaction while the cesarien section. The surgeon satisfaction score at 24 hours will be assessed by VAS (Visual Analogue Scale); Surgeon rate satisfaction on VAS from 0-10, 0 being no satisfaction and 10 being total satisfaction.	1 day