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Completed

NCT Number: NCT05056142

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

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.

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Key information

Conditions

Pregnancy Related

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospitals

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

epidural anesthesia

Procedure

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

Spinal analgesia

Procedure

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

Primary outcomes

  1. The time to perform the block

    Time frame: Intraoperative

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

Secondary outcomes

  1. Mean arterial blood pressure (MAP)

    Time frame: 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

  2. Heart rate (HR)

    Time frame: 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

  3. Number of participnts with Postoperative nausea and vomiting (PONV)

    Time frame: First 24 hours postoperatively

    PONV will be recorded and categorized as 'no PONV, mild PONV, moderate PONV, and severe PONV'

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 24, 2021
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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