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Recruiting NCT06653036

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

No phase Interventional Quality Health Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dural puncture epidural, Standard Epidural Technique.
Who it may be relevant to
Registry conditions: Quality Health Care. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Dural Puncture Epidural Vs Standard Epidural Technique in Parturient Receiving Continuous Labour Epidural Infusion: a Randomized Controlled Trial

Overview

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

Interventions

  • Procedure Dural puncture epidural
    The Dural puncture epidural technique is done by assessing the epidural space using the Touhy needle and puncturing the dura matter with a finer needle.
  • Procedure Standard Epidural Technique
    The Standard Epidural Technique is usually performed by identifying the epidural space using the loss of resistance technique and threading the epidural catheter in the epidural space for administration of analgesic drugs.

Primary outcome measures

  • Pain Assessment [Time frame: At 30 minutes of initiation of infusion]
  • Need for catheter adjustment [Time frame: At 30 minutes of initiation of infusion]
Secondary outcome measures (2)
  • Patient Satisfaction [Time frame: At 30 minutes of initiation of infusion]
  • Assessment of the level of motor Block [Time frame: At 30 minutes after the initiation of infusion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Diagnostic

Study locations

Pakistan · 1 center
  • Aga Khan University — Karachi

Identifiers

NCT: NCT06653036 · 2024-10424-31009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗