Analgesia
Conditions
Brief summary
Subarachnoid block is a widely used anesthetic technique for cesarean section. To improve the quality of analgesia and prolong its duration, the addition of intrathecal opioids to local anesthetics has been encouraged. In a double blind randomized controlled trial, 60 parturient women ASA 2-3 scheduled for elective cesarean delivery under spinal anesthesia will be randomly divided into 2 groups: Group 1 will receive sufentanil 5 μg and Group 2 will receive meperidine 12.5 mg. In every group, 0.5% heavy bupivacaine 10 will be added.
Detailed description
A questionnaire will be used to collect data. Patients' demographic and operative characteristics will be recorded. These include block level, heart rate, mean arterial pressure, nausea, vomiting, shivering and use of vasopressors. Post-operative data include pain, analgesic consumption, nausea and vomiting, as well as patients and surgeons satisfaction.
Interventions
DRUGsufentanil
Patients will receive sufentanil in spinal anesthesia
DRUGmeperidine
Patients will receive meperidine in spinal anesthesia
DRUGBupivacaine
Patients will receive 0.5% heavy bupivacaine in spinal anesthesia
Sponsors
Makassed General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* pregnant women with American Society of Anesthesiologist (ASA) 2-3 * scheduled for elective cesarean section.
Exclusion criteria
* refuse to participate in the study, * requiring emergency obstetric care, * ASA IV or V, * having systemic diseases, * a known fetal anomaly, * placenta previa, * abruption placenta * with a history of hypersensitivity or allergy to any of the study drugs, * operation time longer than 1.5 hour, * blood loss more than 1500 millilitres, * those with any contraindication to the technique proposed,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First analgesic request time | 24 hours post operatively | The duration of effective analgesia is defined as the time from intrathecal injection to first patient analgesic demand |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic requirements | 24 hours post operatively | A questionnaire will be used to record the analgesics consumed by the patients |
Countries
Lebanon
Contacts
Primary ContactSaleh Kanawati, MD
Outcome results
None listed