Epidural Versus Low-dose Spinal for Analgesia of Late First Stage of Labor

Not Applicable

Completed

• Conditions: Pregnancy Related
• Interventions: Procedure: Epidural Anesthesia; Procedure: Spinal Analgesia

• Registration Number: NCT05056142
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-14
• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-15
• Study First Posted: 2021-09-24
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-04
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural Anesthesia	Epidural Anesthesia	Patients will receive epidural analgesia with 15 ml isobaric bupivacaine 0.125% plus fentanyl 2 μg/mL
Spinal Anesthesia	Spinal Analgesia	Patients will receive Spinal analgesia with 5 mg bupivacaine and 25 μg of fentanyl in a 2 ml volume.

Primary Outcome Measures

Name	Time	Method
The time to perform the block	Intraoperative	The time from the preparation of the block until the full injection of anesthetic drugs,

Secondary Outcome Measures

Name	Time	Method
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'
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

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Egypt