Cesarean Section Complications, Local Anesthetic Complication, Regional Anesthesia Morbidity
Conditions
Keywords
cesarean section, intrathecal anesthesia, bupivacaine, morbidity
Brief summary
General anesthesia during pregnancy is associated with several major risks including unanticipated difficult airway, pulmonary aspiration, and specific anesthetic effects on the newborn. Thus, intrathecal anesthesia is the technique of choice for cesarean section. Nevertheless, the main side effect of intrathecal anesthesia is arterial hypotension which depend mainly on the dose of local anesthetic administered intrathecally. To date there is no guidelines nor evidences whic help the anesthetist to precisely estimate the required dose. Most often a standardized dose of 8 to 10 mg of bupivacaine is administered. However, some data suggest that a lower dose may be administered resulting in less frequent arterial hypotension. Nevertheless, a well designed randomized study is lacking.
Detailed description
The present controlled randomized double blind trial was designed to compare 2 intrathecal dose of bupivacaine for cesarean section * a standard dose of 10 mg of intrathecal bupivacaine associated with morphine 100 micrograms and sufentanil 3 micrograms * a height-calculated dose of bupivacaine (0.05 mg per cm of height) on associated with morphine 100 micrograms and sufentanil 3 micrograms The main outcome is the rate of hypotension defined as a 20% or more decrease in systolic arterial pressure. Secondary outcomes focused on intrathecal anesthesia efficacy, success or failure and on interventions required to manage arterial hypotension
Interventions
OTHERstandardized dose
intrathecal anesthesia with 10 mg of bupivacaine
OTHERadjusted dose
intrathecal anesthesia with 0.05 mg of bupivacaine par cm of patient's height
Sponsors
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Neither the patient nor the care provider nor the outcome assessor will know the allocation group. Bupivacaine syringe will be prepare, according to the protocol, by a separate anesthetist not involved in the care of the patient. The solution in both groups will have the same volume.
Intervention model description
randomized controlled double blind trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* scheduled cesarean section with intrathecal anesthesia * term pregnancy \> 35 weeks * signed informed consent
Exclusion criteria
* unscheduled or emergent cesarean section * any contra indication to intrathecal anesthesia * any antihypertensive drug prescribed to control arterial pressure during pregnancy * pre-eclampsia and eclampsia * history of Marfan or Ehlers Danlos disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of arterial hypotension | 4 hours since the start of intrathecal bupivacaine administration | rate of arterial hypotension defined as a 20% or more decrease in systolic arterial pressure as compared with baseline systolic arterial pressure measured at 32 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| vasopressor total dose | 4 hours since the start of intrathecal bupivacaine administration | total dose of vasopressor administered during intrathecal anesthesia |
| metameric level of intrathecal anesthesia | 4 hours since the start of intrathecal bupivacaine administration | clinical evaluation of the metameric level obtained during intrathecal anesthesia |
| lower limb motor block at the end of the caesarean section | 5 min after the end of caesarean section at newborn umbilical cord clamp | lower limb motor block at the end of the caesarean section using Bromage score |
| rate of need for general anesthesia | 5 min after the end of caesarean section at newborn umbilical cord clamp | rate of need for general anesthesia because of intrathecal anesthesia failure or overdose |
| patient's comfort self evaluation | 4 hours since the start of intrathecal bupivacaine administration | patient's comfort self evaluation using a verbal rating scale from 0 (uncomfortable) to 10 (totally comfortable) |
Countries
France
Contacts
Primary Contactjean-luc hanouz, M.D, Ph.D
Backup Contactthérèse simonet, M.D.
Outcome results
None listed