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

NCT05056142 | Completed

• 1 other identifier: FMASU R 155/2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The time to perform the block

  The time from the preparation of the block until the full injection of anesthetic drugs,

  Intraoperative

Secondary Outcomes (3)

• Mean arterial blood pressure (MAP)

  Intraoperative

• Heart rate (HR)

  Intraoperative

• Number of participnts with Postoperative nausea and vomiting (PONV)

  First 24 hours postoperatively

Study Arms (2)

Epidural Anesthesia

ACTIVE COMPARATOR

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

Procedure: Epidural Anesthesia

Spinal Anesthesia

ACTIVE COMPARATOR

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

Procedure: Spinal Analgesia

Interventions

Epidural Anesthesia PROCEDURE

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

Epidural Anesthesia

Spinal Analgesia PROCEDURE

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

Spinal Anesthesia

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Interventions

Anesthesia, Epidural

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 24, 2021
• Study Start: September 14, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Locations

EG (1)