Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05487196 | Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia | PHASE2 | COMPLETED | 88 | — | — | Sep 28, 2022 | Jul 31, 2023 | Apr 27, 2025 | 1 | United States |
Pain score AREA UNDER THE CURVE (AUC), which is a calculated area under curve using the trapezoidal rule, where pain scores measured from 0 (no pain) to 10 (worst imaginable pain) are on the y axis, and time is on the x axis (pain scores were measured at 5 minutes, 10 minutes,15 minutes, 30 minutes after epidural initiation for the primary outcome assessment). The scale for AUC is not 0-10 but rather is completely dependent upon the area generated under the curve created by pain scores for the first 30 minutes of epidural analgesia (primary outcome time frame): in this case, the scale is 0-250 pain units\*minute, given maximum pain score possibility of 10 and time period of 30 minutes. The units of AUC are the units of Y axis times units of X axis, in this case, pain score units \* minutes. Pain AUC was compared between Fentanyl, Clonidine and Dexmedetomidine groups.
| Arm | Type | Description |
|---|---|---|
| Clonidine | EXPERIMENTAL | Bolus dose at epidural initiation, through the epidural catheter: 10 ml Ropivacaine 0.1 % combined with a single dose of Clonidine 60 mcg |
| Dexmedetomidine | EXPERIMENTAL | Bolus dose at epidural initiation, through the epidural catheter: 10 ml Ropivacaine 0.1 % combined with a single dose of Dexmedetomidine 30 mcg |
| Ropivacaine + Fentanyl | ACTIVE_COMPARATOR | Bolus dose at epidural initiation, through the epidural catheter: 10 ml Ropivacaine 0.1 % combined with a single dose of Fentanyl 100mcg |
| Name | Type | Description |
|---|---|---|
| Clonidine | DRUG | Clonidine belongs to the drug classification of antihypertensives |
| Dexmedetomidine | DRUG | Dexmedetomidine belongs to the drug classification of sedatives |
| Fentanyl | DRUG | Fentanyl belongs to the drug classification of analgesic opioid agonists and is used as the standard of care |
| Ropivacaine | DRUG | Ropivacaine belongs to the drug classification of local or regional anesthesia for surgery and is used as standard of care |
Pregnant minors were not enrolled in this trial. Inclusion Criteria: * Pregnant women 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 * V...