Caeserian Section, Local Anesthetic, Regional Anesthesia
Conditions
Brief summary
SPINAL anesthesia is commonly used for cesarean section, and it has become a popular practice to add opioids to spinal solutions to enhance and prolong intraoperative and postoperative analgesia. high incidence of side effects was noted. is there any alternative?
Interventions
DRUGcontrol group
spinal anesthesia with 10 mg hyperbaric Bupivacaïne 0,5% + 2,5 µ Sufentanyl + 100 µ of intrathecal Morphine+ infiltration catheter with saline 5 ml/h
DRUGinfiltration group
spinal anesthesia with 10 mg hyperbaric Bupivacaïne 0,5% + 2,5 µ Sufentanyl + 1ml of saline + infiltration catheter with 5 ml/h of Bupivacaïne 0,125%.
Sponsors
Tunisian Military Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* ASA physical status I-II * 18-45 years of age, inclusive * elective caeserean section under spinal anesthesia
Exclusion criteria
* \- contraindications to spinal anesthesia (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area) * existing neurological deficit * inability to understand the informed consent and demands of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogic Scale | until 48 hours postoperative | quality of postoperative analgesia |
Secondary
| Measure | Time frame |
|---|---|
| occurrence of complications | 48 hours post operative |
| total dose of morphine consumption in mg | during 48 hours post operative |
Outcome results
None listed