Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia
Study Details
Study Description
Brief Summary
The purpose of this trial is to compare the effectiveness of labor analgesia with clonidine, dexmedetomidine, or fentanyl (standard care) adjuncts.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Early Phase 1 |
Detailed Description
This study is significant because it can potentially alternative 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 fo administration; and 2) epidural fentanyl or sufentanil adminstration for labor can potentially interfere with the accuracy of urine drug screening in the postpartum period.
Regarding the scope of the problem: A retrospective study evaluated the incidence of maternal opiate usage using a database that compiled information from 7.4 million discharges in 44 states. It shows that the maternal consumption of opioids has increased nearly fivefold in a 9-year observation period (2000-2009) while others report prevalence of opioid use disorder during pregnancy Increasing by 127% from 1998 to 2011. It is estimated that 4.5% of pregnant women aged 15-44 years are using illicit or prescription opioid medications, which emphasizes the importance of this issue.
Tailoring the approach to labor pain management in the population of parturient that are at risk for complex pain management is the cornerstone to an individualized approach, leading to optimal care. This approach may potentially be achieved by substituting the opioid in the epidural solution with another adjuvant such as clonidine or dexmedetomidine, two alpha2-adrenergic agonists.
Some existing literature suggests that dexmedetomidine and clonidine are adjuncts to local anesthetics that offer a faster onset and a better quality of analgesia for patients requiring labor analgesia. Further studies are required to precise the dosage and regimens in a population of laboring patients.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Clonidine Bolus dose at epidural initiation, through the epidural catheter: 10 ml Ropivacaine 0.1 % combined with a single dose of Clonidine 60 mcg |
Drug: Clonidine
Clonidine belongs to the drug classification of antihypertensives
Drug: Ropivacaine
Ropivacaine belongs to the drug classification of local or regional anesthesia for surgery and is used as standard of care
|
| Experimental: Dexmedetomidine Bolus dose at epidural initiation, through the epidural catheter: 10 ml Ropivacaine 0.1 % combined with a single dose of Dexmedetomidine 30 mcg |
Drug: Dexmedetomidine
Dexmedetomidine belongs to the drug classification of sedatives
Drug: Ropivacaine
Ropivacaine belongs to the drug classification of local or regional anesthesia for surgery and is used as standard of care
|
| Active Comparator: Ropivacaine + Fentanyl Bolus dose at epidural initiation, through the epidural catheter: 10 ml Ropivacaine 0.1 % combined with a single dose of Fentanyl 100mcg |
Drug: Fentanyl
Fentanyl belongs to the drug classification of analgesic opioid agonists and is used as the standard of care
Drug: Ropivacaine
Ropivacaine belongs to the drug classification of local or regional anesthesia for surgery and is used as standard of care
|
Outcome Measures
Primary Outcome Measures
- Pain Scores [30 minutes after initiation of epidural analgesia]
Pain as defined by the Numeric Rating Score (NRS) in which the minimum score of 0 indicates no pain at all and the maximum score of 10 indicates the worst pain imaginable.
Secondary Outcome Measures
- Pain Scores [10 minutes after initiation of epidural analgesia]
Pain as defined by the Numeric Rating Score (NRS) in which the minimum score of 0 indicates no pain at all and the maximum score of 10 indicates the worst pain imaginable.
- Pain Scores [60 minutes after initiation of epidural analgesia]
Pain as defined by the Numeric Rating Score (NRS) in which the minimum score of 0 indicates no pain at all and the maximum score of 10 indicates the worst pain imaginable.
- Pain Scores [After delivery]
Pain as defined by the Numeric Rating Score (NRS) in which the minimum score of 0 indicates no pain at all and the maximum score of 10 indicates the worst pain imaginable.
- Obstetric outcomes related to delivery details [Duration of labor]
This will be measured by yes/no response to the following outcomes: preterm delivery, cesarean delivery, severe maternal morbidity and mortality
- Hemodynamic outcomes [Duration of labor]
This will be measured by yes/no response to the following outcomes: increased cardiac output, expanded blood volume, reduced systemic vascular resistance and blood pressure
- Nausea [Duration of labor]
Patient self-report yes/no response
- Vomiting [Duration of labor]
Patient self-report yes/no response
- Shivering [Duration of labor]
Patient self-report yes/no response
- Pruritus [Duration of labor]
Patient self-report yes/no response
- Patient Treatment Satisfaction [Duration of labor]
Patient self-report yes/no response
- Fetal and Newborn Outcomes [Duration of labor]
This will be measured by yes/no response to any adverse fetal or birth outcome
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UPMC Magee-Womens Hospital | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- Grace Lim, MD, MS
Investigators
- Principal Investigator: Grace Lim, MD, MS, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY22030095