Effect of Auto-Bolus Interval on Analgesic Quality During Labor Analgesia With Dural Puncture Epidural

Last updated: March 29, 2024
Sponsor: Ataturk University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Treatment

Group II: 60 Min Interval Time

Group I: 30 Min Interval Time

Clinical Study ID

NCT06329713
2024-03/11
  • Ages 25-45
  • Female
  • Accepts Healthy Volunteers

Study Summary

It is aimed in this study to compare the effect of changing the interval time for programmed auto boluses of local anaesthetics on the total anesthetic consumption and quality of labor analgesia with dural puncture epidural technique.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy nulliparous women
  2. American Society of Anaesthesiology Score of II
  3. During active labor
  4. At weeks 37-42.
  5. Singlet vertex presentation
  6. Cervical dilation <5 cm at the request of labor analgesia
  7. VAS score >40

Exclusion

Exclusion Criteria:

  1. Age <20 or >45,
  2. Morbid obesity
  3. Presence of pregnancy-related comorbidities (e.g: gestational diebetes, gestationalhypertension and preeclampsia)
  4. History of drug abuse
  5. Contrindication for neuraxial blocks
  6. Conditions that increase the risk of need for cesarean section (e.g. placenta previa,uterus abnormalities or surgeries)
  7. Diagnosed fetal abnormalities
  8. Cases where dura gets punctured unintendedly with the epiduralneedle
  9. Cases where flow of cerebrospinal fluid (CSF) is not observed after dural puncture
  10. Cases where a cesarean section is performed at any stage of labor
  11. Cases where labor is completed in 1 hour from the start of analgesia procedure. Exclusion Criteria:

Study Design

Total Participants: 54
Treatment Group(s): 2
Primary Treatment: Group II: 60 Min Interval Time
Phase:
Study Start date:
March 15, 2024
Estimated Completion Date:
August 01, 2025

Study Description

This study will be conducted as a prospective randomized, controlled, double-blind trial following the approval of the ethical committee at Atatürk University Medical Faculty Hospital and after obtaining written consent from the participating patients. The study will include pregnant women aged 20 to 45 with American Society of Anesthesiologists (ASA) II classification, full-term, nulliparous and singleton pregnancies. Using a randomisation procedure, the participants will be allocated into two equal groups: Group I and Group II.

Connect with a study center

  • Atatürk University

    Erzurum,
    Turkey

    Active - Recruiting

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