Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia: A Randomized Controlled Trial (CLASSIER Trial)

  • STATUS
    Recruiting
  • End date
    Sep 1, 2024
  • participants needed
    160
  • sponsor
    Grace Lim, MD, MS
Updated on 27 October 2022
Accepts healthy volunteers

Summary

The purpose of this randomized controlled trial is to compare the effectiveness of epidural clonidine, dexmedetomidine, or fentanyl adjuncts for labor analgesia.

Description

Adjuncts for epidural labor analgesia have remained unchanged for decades, whereas changes in patient population and the opioid epidemic have created an increased demand for non-opioid alternative adjuncts to limit peripartum opioid exposure. This study aims to identify effective alternative and non-opioid adjunctive agents for epidural labor analgesia.

The opioid crisis in the United States has translated to an increasing number of pregnant women requiring care for labor and delivery. These trends have resulted in new questions about alternative epidural analgesia adjuncts besides lipophilic opioids (e.g., fentanyl and sufentanil) because: 1) many people with OUD desire to avoid opioids in all formulations and routes of administration; and 2) epidural fentanyl or sufentanil administration for labor can potentially interfere with the accuracy of urine drug screening in the postpartum period.

Some existing literature suggests that dexmedetomidine and clonidine are viable adjuncts to local anesthetics that offer a faster onset and a better quality of analgesia for patients requiring labor analgesia. However, the relative effectiveness of these adjunctive agents for labor analgesia have not been compared head to head. Better data on how these adjuncts compare with each other for labor analgesia efficacy, can result in more informed clinical care strategies.

Details
Condition Pregnancy Related
Treatment Dexmedetomidine, Fentanyl, ropivacaine, clonidine
Clinical Study IdentifierNCT05487196
SponsorGrace Lim, MD, MS
Last Modified on27 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

>/= 18 years of age
American Society of Anesthesiologists (ASA) Physical Status 2 or 3
Term pregnancy (>37 gestational weeks)
Planning epidural labor analgesia
Singleton pregnancy
Vertex presentation
Planned vaginal delivery

Exclusion Criteria

Pre-eclampsia with or without severe features
New initiation of antihypertensive agent within 24 hours prior to enrollment
Uncontrolled systemic comorbidities [i.e., diabetes, hepatic, renal or cardiac]
Known or suspected fetal abnormalities
Allergy to study agents
Contra-indication to neuraxial anesthesia
Inability to communicate or participate in study procedures
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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