Césarcaïne: Prilocaine or Bupivacaine for Spinal Anesthesiain Pregnant
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Hyperbaric Bupivacaine spinal anesthesia for planned cesarean sections control group |
Drug: spinal anesthesia
spinal anesthesia for planned cesarean sections
|
| Active Comparator: Hyperbaric Prilocaïne spinal anesthesia for planned cesarean sections |
Drug: spinal anesthesia
spinal anesthesia for planned cesarean sections
|
Outcome Measures
Primary Outcome Measures
- 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
- The upper sensory level [15 minutes after the LA injection]
The upper sensory level obtained 15 minutes after the LA injection
- Hypotensive episodes [1 day]
Hypotensive episodes
- 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 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
- 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
- The presence of neuro-sensory disorders within 24 hours postoperatively [1 day]
The presence of neuro-sensory disorders within 24 hours postoperatively
- 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
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Uhmontpellier | Montpellier | France | 34295 |
Sponsors and Collaborators
- University Hospital, Montpellier
- Hopital Saint Roch
Investigators
- Principal Investigator: christophe DADURE, University Hospital, Montpellier
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UF9859