Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia
NCT ID: NCT05487196
Last Updated: 2025-04-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
88 participants
INTERVENTIONAL
2022-09-28
2023-07-31
Brief Summary
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Detailed Description
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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.
This trial was initially initiated as a superiority design. After further scientific input, it was decided that a non-inferiority design would be more informative for the clinical question at hand. The hypothesis is that clonidine (Group C) and dexmedetomidine (Group D) are non-inferior to fentanyl (Group F) (usual care) as adjuncts for epidural labor analgesia. The null hypothesis is that clonidine and dexmedetomidine are inferior to fentanyl as adjuncts for epidural labor analgesia. Clinical Protocol specific methodology did not change throughout the trial and the full trial protocol document can be found in the relevant section below. An updated statistical analysis plan includes updated sample size calculations and has been reported to account for the noninferiority analysis plan. No data was analyzed prior to the completion of all data collection procedures.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Clonidine
Bolus dose at epidural initiation, through the epidural catheter:
10 ml Ropivacaine 0.1 % combined with a single dose of Clonidine 60 mcg
Clonidine
Clonidine belongs to the drug classification of antihypertensives
Ropivacaine
Ropivacaine belongs to the drug classification of local or regional anesthesia for surgery and is used as standard of care
Dexmedetomidine
Bolus dose at epidural initiation, through the epidural catheter:
10 ml Ropivacaine 0.1 % combined with a single dose of Dexmedetomidine 30 mcg
Dexmedetomidine
Dexmedetomidine belongs to the drug classification of sedatives
Ropivacaine
Ropivacaine belongs to the drug classification of local or regional anesthesia for surgery and is used as standard of care
Ropivacaine + Fentanyl
Bolus dose at epidural initiation, through the epidural catheter:
10 ml Ropivacaine 0.1 % combined with a single dose of Fentanyl 100mcg
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
FEMALE
Yes
Sponsors
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Grace Lim, MD, MS
OTHER
Responsible Party
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Grace Lim, MD, MS
Associate Professor
Principal Investigators
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Grace Lim, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STUDY22030095
Identifier Type: -
Identifier Source: org_study_id
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