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

NCT ID: NCT05056142

Last Updated: 2022-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-14
• Study Completion Date: 2022-10-01

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.

Conditions

Pregnancy Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Epidural Anesthesia

Patients will receive epidural analgesia with 15 ml isobaric bupivacaine 0.125% plus fentanyl 2 μg/mL

Group Type: ACTIVE_COMPARATOR

Epidural Anesthesia

Intervention Type: PROCEDURE

Patients will receive epidural analgesia with 15 ml isobaric bupivacaine 0.125% plus fentanyl 2 μg/mL.

Spinal Anesthesia

Patients will receive Spinal analgesia with 5 mg bupivacaine and 25 μg of fentanyl in a 2 ml volume.

Group Type: ACTIVE_COMPARATOR

Spinal Analgesia

Intervention Type: PROCEDURE

Patients will receive Spinal analgesia with 5 mg bupivacaine and 25 μg of fentanyl in a 2 ml volume.

Interventions

Epidural Anesthesia

Patients will receive epidural analgesia with 15 ml isobaric bupivacaine 0.125% plus fentanyl 2 μg/mL.

Intervention Type: PROCEDURE

Spinal Analgesia

Patients will receive Spinal analgesia with 5 mg bupivacaine and 25 μg of fentanyl in a 2 ml volume.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Amin Mohammed Alansary Amin Ahmed Helwa

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University Hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU R 155/2021

Identifier Type: -

Identifier Source: org_study_id