Pregnancy Related
Conditions
Brief summary
The aim of this study is to compare the effect of epidural analgesia versus low-dose spinal analgesia in parturient in the late first stage of labor regarding time needed to perform the block, duration of the intra- and postoperative analgesia and incidence of procedure related adverse events.
Interventions
PROCEDUREEpidural Anesthesia
Patients will receive epidural analgesia with 15 ml isobaric bupivacaine 0.125% plus fentanyl 2 μg/mL.
PROCEDURESpinal Analgesia
Patients will receive Spinal analgesia with 5 mg bupivacaine and 25 μg of fentanyl in a 2 ml volume.
Sponsors
Ain Shams University
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 40 Years
Healthy volunteers
No
Inclusion criteria
* Parturient with normal vaginal delivery in late first stage of labor (cervical dilatation ≥ 6 cm by examination) * Aged 18-40 years old * Single, term pregnant with normal fetal heart rate * Request neuroaxial analgesia
Exclusion criteria
* Parturient who refuses to participate, * American Society of Anesthesiologists (ASA) physical status \>II, * Body mass index more than 35 kg/m2 * Severe pre-eclampsia or eclampsia * Uncontrolled thyrotoxicosis * Cardiovascular troubles (e.g. stenotic valvular heart disease or cardiomyopathy) * Increased intracranial tension due to a space-occupying lesion * Any contraindication to regional anesthesia such as local skin or soft tissue infection, coagulopathy or receiving anticoagulant therapy, thrombocytopenic, uncorrected hypovolemia, preexisting neurologic deficits, spinal deformity or previous spine surgery. * Hypersensitivity to the study drugs * Parturient who scheduled for emergency cesarean section due to fetal distress, antepartum hemorrhage, multiple gestation or fetal malpresentation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The time to perform the block | Intraoperative | The time from the preparation of the block until the full injection of anesthetic drugs, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean arterial blood pressure (MAP) | Intraoperative | MAP will be recorded at baseline; 5 minutes prior to the neuroaxial block, and at 5 minutes, 10 minutes, 15 minutes, and 20 minutes after the injection of the local anesthetic and then every 15 minutes till the end of third stage of labor |
| Heart rate (HR) | Intraoperative | HR will be recorded at baseline; 5 minutes prior to the neuroaxial block, and at 5 minutes, 10 minutes, 15 minutes, and 20 minutes after the injection of the local anesthetic and then every 15 minutes till the end of third stage of labor |
| Number of participnts with Postoperative nausea and vomiting (PONV) | First 24 hours postoperatively | PONV will be recorded and categorized as 'no PONV, mild PONV, moderate PONV, and severe PONV' |
Countries
Egypt
Outcome results
None listed