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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05487196
Other study ID # STUDY22030095
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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