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Dural Puncture Epidural Vs Standard Epidural Technique in Parturient Receiving Continuous Labour Epidural Infusion

A

Aga Khan University

Status

Enrolling

Conditions

Quality Health Care

Treatments

Procedure: Standard Epidural Technique
Procedure: Dural puncture epidural

Study type

Interventional

Funder types

Other

Identifiers

NCT06653036
2024-10424-31009

Details and patient eligibility

About

The goal of this study is to evaluate the quality and safety of labor analgesia by comparing the use of Dural puncture epidural technique to Standard epidural technique while maintaining labor analgesia by means of continuous epidural infusion in parturient. The main questions it aims to answer are

  • Effectiveness and quality of labor analgesia
  • Frequency of catheter adjustments
  • Need for catheter replacements
  • Incidence of failed regional anesthesia requiring conversion to general anesthesia

Enrollment

38 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Nulliparous / Multiparous women
  • Age >18 years
  • ASA 1 & 2
  • Singleton vertex presentation
  • Gestational age 37-42 weeks
  • Parturient with established labor and pain score ≥ 3

Exclusion criteria

  • Major cardiac disease
  • History of chronic pain
  • Chronic opioid user
  • Platelet count < 70 x 109/L
  • spinal cord anomalies
  • Use of anticoagulants
  • Allergic to local anesthetics
  • Patients with preeclampsia/ eclampsia
  • Known fetal anomalies

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

38 participants in 2 patient groups

DPE group
Active Comparator group
Description:
Participants who receive the dural puncture epidural (DPE) for labor analgesia.
Treatment:
Procedure: Dural puncture epidural
SET group
Active Comparator group
Description:
Participants who will be receiving standard epidural technique (SET) for labor analgesia.
Treatment:
Procedure: Standard Epidural Technique

Trial contacts and locations

1

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Central trial contact

Sehrish Khan, MBBS, FCPS; Samina Ismail, MBBS, FCPS

Data sourced from clinicaltrials.gov

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