Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05487196
• Other study ID #: STUDY22030095
• Status: Completed
• Phase: Phase 2
• Start date: September 28, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: October 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 opioid or substance use disorder 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, which has implications for postpartum social services considerations.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Greater than 18 years of age

• American Society of Anesthesiologists (ASA) Physical Status 2 or 3

• Term pregnancy (greater than 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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Drug:
• Clonidine
Clonidine belongs to the drug classification of antihypertensives
• Dexmedetomidine
Dexmedetomidine belongs to the drug classification of sedatives
• Fentanyl
Fentanyl belongs to the drug classification of analgesic opioid agonists and is used as the standard of care
• Ropivacaine
Ropivacaine belongs to the drug classification of local or regional anesthesia for surgery and is used as standard of care

Locations

Country	Name	City	State
United States	UPMC Magee-Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Grace Lim, MD, MS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Burden, AUC (30 minutes)	Pain score area under the curve (AUC) where pain scores are measured from 0 (no pain) to 10 (worst imaginable pain), for the duration of epidural analgesia. Pain AUC will be compared between Fentanyl, Clonidine and Dexmedetomidine groups.	First 30 minutes of analgesia
Secondary	Pain Scores (30 minutes)	Average (and standard deviations) pain scores within each of the three medication groups. Pain scores are measured from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be compared between Fentanyl, Clonidine and Dexmedetomidine groups.	30 minutes after initiation of epidural analgesia
Secondary	Pain Burden, AUC (120 minutes)	Pain score area under the curve (AUC) where pain scores are measured from 0 (no pain) to 10 (worst imaginable pain), for the duration of epidural analgesia. Pain AUC will be compared between Fentanyl, Clonidine and Dexmedetomidine groups.	First 120 minutes of analgesia