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

Epidural Versus Low-dose Spinal for Analgesia of Late First Stage of Labor: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related
• Intervention / Treatment: Procedure: Epidural Anesthesia; Procedure: Spinal Analgesia

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Epidural Anesthesia; Patients will receive epidural analgesia with 15 ml isobaric bupivacaine 0.125% plus fentanyl 2 μg/mL	Procedure: Epidural Anesthesia; Patients will receive epidural analgesia with 15 ml isobaric bupivacaine 0.125% plus fentanyl 2 μg/mL.
Active Comparator: Spinal Anesthesia; Patients will receive Spinal analgesia with 5 mg bupivacaine and 25 μg of fentanyl in a 2 ml volume.	Procedure: Spinal Analgesia; Patients will receive Spinal analgesia with 5 mg bupivacaine and 25 μg of fentanyl in a 2 ml volume.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time to perform the block	The time from the preparation of the block until the full injection of anesthetic drugs,	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean arterial blood pressure (MAP)	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	Intraoperative
Heart rate (HR)	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	Intraoperative
Number of participnts with Postoperative nausea and vomiting (PONV)	PONV will be recorded and categorized as 'no PONV, mild PONV, moderate PONV, and severe PONV'	First 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 4, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: FMASU R 155/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No