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

A

Ain Shams University

Status

Completed

Conditions

Pregnancy Related

Treatments

Procedure: Spinal Analgesia
Procedure: Epidural Anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT05056142
FMASU R 155/2021

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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