Prilocaine or Bupivacaine for Spinal Anesthesiain Pregnant
- Conditions
- Cesarean
- Interventions
- Drug: spinal anesthesia
- Registration Number
- NCT03433976
- Lead Sponsor
- University Hospital, Montpellier
- Brief 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.
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 50
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hyperbaric Bupivacaine spinal anesthesia spinal anesthesia for planned cesarean sections control group Hyperbaric Prilocaïne spinal anesthesia spinal anesthesia for planned cesarean sections
- Primary Outcome Measures
Name Time Method duration of motor block up to 6 hours 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
- Secondary Outcome Measures
Name Time Method The upper sensory level 15 minutes after the LA injection The upper sensory level obtained 15 minutes after the LA injection
The time between injection and incision 1 day The time between injection and incision
The duration of the intervention 1 day The duration of the intervention
The presence of neuro-sensory disorders within 24 hours postoperatively 1 day The presence of neuro-sensory disorders within 24 hours postoperatively
Statifaction of the Surgeon 1 day 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.
The time to return to the standard maternity ward 1 day The time to return to the standard maternity ward
APGAR score of newborns at birth 1 day 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.The delay between spinal anesthesia and the first emergency analgesic injection 1 day The delay between spinal anesthesia and the first emergency analgesic injection
The presence of post lumbar puncture syndrome 1 day The presence of post lumbar puncture syndrome
score de satisfaction 1 day 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
Hypotensive episodes 1 day Hypotensive episodes
Assessment of pain (VAS) 1 day 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..
The delay between spinal anesthesia and the first injection of second-line analgesia 1 day The delay between spinal anesthesia and the first injection of second-line analgesia : delay between spinal anesthesia ans the need of rescue analgesia
Trial Locations
- Locations (1)
Uhmontpellier
🇫🇷Montpellier, France