Trial Outcomes & Findings for Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia (NCT NCT05487196)
NCT ID: NCT05487196
Last Updated: 2025-04-27
Results Overview
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.
COMPLETED
PHASE2
88 participants
First 30 minutes of analgesia
2025-04-27
Participant Flow
Participant flow numbers reflect mother-fetus dyads (1 mother + 1 infant per dyad). Intervention groups were assigned at the maternal level.
Pregnant subjects were enrolled at the time of admission to labor and delivery. Both mothers and infants were considered enrolled for the purpose of capturing specific infant information from the infant medical record after delivery (i.e., Apgar scores, cord gases). However, only mothers received the study medication for labor pain control. All other outcomes were assessed on maternal subjects only. Enrollment number \& number of subjects started/completed represents the number of dyads enrolled.
Participant milestones
| Measure |
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
Pregnant subjects were enrolled at the time of admission to labor and delivery. Both mothers and infants were considered enrolled for the purpose of capturing specific infant information from the infant medical record after delivery (i.e., Apgar scores, cord gases). However, only mothers received the study medication for labor pain control. All other outcomes were assessed on maternal subjects only. Enrollment number \& number of subjects started/completed represents the number of dyads enrolled.
|
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
Pregnant subjects were enrolled at the time of admission to labor and delivery. Both mothers and infants were considered enrolled for the purpose of capturing specific infant information from the infant medical record after delivery (i.e., Apgar scores, cord gases). However, only mothers received the study medication for labor pain control. All other outcomes were assessed on maternal subjects only. Enrollment number \& number of subjects started/completed represents the number of dyads enrolled.
|
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
Pregnant subjects were enrolled at the time of admission to labor and delivery. Both mothers and infants were considered enrolled for the purpose of capturing specific infant information from the infant medical record after delivery (i.e., Apgar scores, cord gases). However, only mothers received the study medication for labor pain control. All other outcomes were assessed on maternal subjects only. Enrollment number \& number of subjects started/completed represents the number of dyads enrolled.
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
29
|
|
Overall Study
COMPLETED
|
24
|
22
|
23
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only female participants.
Baseline characteristics by cohort
| Measure |
Clonidine (Maternal)
n=24 Participants
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 (Maternal)
n=22 Participants
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 (Maternal)
n=23 Participants
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
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
>=65 years
|
0 Participants
n=24 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=69 Participants
|
|
Age, Continuous
|
30.5 years
STANDARD_DEVIATION 4.1 • n=24 Participants
|
32 years
STANDARD_DEVIATION 3.5 • n=22 Participants
|
31.5 years
STANDARD_DEVIATION 3.9 • n=23 Participants
|
31.33 years
STANDARD_DEVIATION 3.83 • n=69 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=69 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=24 Participants
|
22 Participants
n=22 Participants
|
23 Participants
n=23 Participants
|
69 Participants
n=69 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=24 Participants • Only female participants.
|
22 Participants
n=22 Participants • Only female participants.
|
23 Participants
n=23 Participants • Only female participants.
|
69 Participants
n=69 Participants • Only female participants.
|
|
Sex: Female, Male
Male
|
0 Participants
n=24 Participants • Only female participants.
|
0 Participants
n=22 Participants • Only female participants.
|
0 Participants
n=23 Participants • Only female participants.
|
0 Participants
n=69 Participants • Only female participants.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: First 30 minutes of analgesiaPopulation: Maternal only
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.
Outcome measures
| Measure |
Clonidine
n=24 Participants
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
n=22 Participants
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
n=23 Participants
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
|
|---|---|---|---|
|
Pain Burden, AUC (30 Minutes)
|
101 pain units*minutes
Interval 38.0 to 138.0
|
67 pain units*minutes
Interval 41.0 to 100.0
|
39 pain units*minutes
Interval 22.0 to 72.0
|
SECONDARY outcome
Timeframe: First 120 minutes of analgesiaPopulation: Maternal only
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, 60 minutes, 90 minutes and 120 minutes after epidural initiation). 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 120 minutes of epidural analgesia: in this case, the scale is 0-850 pain units\*minute, given maximum pain score possibility of 10 and time period of 120 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.
Outcome measures
| Measure |
Clonidine
n=24 Participants
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
n=22 Participants
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
n=23 Participants
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
|
|---|---|---|---|
|
Pain Burden, AUC (120 Minutes)
|
133 pain units*minutes
Interval 38.0 to 217.0
|
67 pain units*minutes
Interval 41.0 to 154.0
|
45 pain units*minutes
Interval 28.0 to 132.0
|
SECONDARY outcome
Timeframe: 15 minutes after initiation of epidural analgesiaPopulation: Maternal only
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.
Outcome measures
| Measure |
Clonidine
n=24 Participants
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
n=22 Participants
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
n=23 Participants
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
|
|---|---|---|---|
|
Pain Scores
|
2.8 score on a scale
Standard Deviation 2.7
|
1.9 score on a scale
Standard Deviation 2.5
|
1.0 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 30 minutes after initiation of epidural analgesiaPopulation: Maternal only
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.
Outcome measures
| Measure |
Clonidine
n=24 Participants
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
n=22 Participants
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
n=23 Participants
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
|
|---|---|---|---|
|
Pain Scores
|
2.0 score on a scale
Standard Deviation 2.4
|
0.9 score on a scale
Standard Deviation 2.0
|
0.8 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Immediately after deliveryPopulation: Maternal only
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.
Outcome measures
| Measure |
Clonidine
n=24 Participants
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
n=22 Participants
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
n=23 Participants
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
|
|---|---|---|---|
|
Pain Scores
|
1.7 score on a scale
Standard Deviation 2.8
|
0.8 score on a scale
Standard Deviation 2.3
|
0.5 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: At the time of deliveryPopulation: Maternal only
This will be measured by yes/no response to cesarean delivery mode of delivery outcome. We report the raw numbers of patients who did receive a cesarean delivery according to group.
Outcome measures
| Measure |
Clonidine
n=24 Participants
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
n=22 Participants
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
n=23 Participants
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
|
|---|---|---|---|
|
Cesarean Delivery
|
3 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Between 0-120 min after study drug administrationPopulation: Maternal only
This is measured as any hypotensive event occurring any time between 0-120 min after study drug administration.
Outcome measures
| Measure |
Clonidine
n=24 Participants
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
n=22 Participants
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
n=23 Participants
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
|
|---|---|---|---|
|
Hypotension
|
13 Participants
|
10 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 0-120 min after study drug administrationPopulation: Maternal only
Patient self-report of nausea at any time between 0-120 min after study drug administration
Outcome measures
| Measure |
Clonidine
n=24 Participants
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
n=22 Participants
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
n=23 Participants
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
|
|---|---|---|---|
|
Nausea
|
5 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 0-120 min after study drug administrationPopulation: Maternal only
Patient self-report of vomiting at any time between 0-120 min after study drug administration
Outcome measures
| Measure |
Clonidine
n=24 Participants
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
n=22 Participants
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
n=23 Participants
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
|
|---|---|---|---|
|
Vomiting
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 0-120 min after study drug administrationPopulation: Maternal only
Patient self-report of shivering at any time between 0-120 min after study drug administration
Outcome measures
| Measure |
Clonidine
n=24 Participants
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
n=22 Participants
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
n=23 Participants
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
|
|---|---|---|---|
|
Shivering
|
6 Participants
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 0-120 min after study drug administrationPopulation: Maternal only
Patient self-report of pruritus at any time between 0-120 min after study drug administration
Outcome measures
| Measure |
Clonidine
n=24 Participants
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
n=22 Participants
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
n=23 Participants
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
|
|---|---|---|---|
|
Pruritus
|
3 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Immediately after deliveryPopulation: Maternal only
Patient self-report regarding satisfaction with analgesia on a scale of 1-10; 1 = not satisfied, 10 = the most satisfied.
Outcome measures
| Measure |
Clonidine
n=24 Participants
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
n=22 Participants
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
n=23 Participants
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
|
|---|---|---|---|
|
Patient Treatment Satisfaction
|
10 score on a scale
Interval 8.0 to 10.0
|
10 score on a scale
Interval 9.0 to 10.0
|
10 score on a scale
Interval 8.0 to 10.0
|
SECONDARY outcome
Timeframe: 1 minute after deliveryPopulation: Neonatal only
The Apgar score is a method of assessing newborn health at the time of delivery. Score range 0 to 10 where 0 is poor health and 10 is the best health.
Outcome measures
| Measure |
Clonidine
n=24 Participants
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
n=22 Participants
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
n=23 Participants
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
|
|---|---|---|---|
|
Newborn Apgar Score
|
9 score on a scale
Interval 8.0 to 9.0
|
8 score on a scale
Interval 8.0 to 9.0
|
8.5 score on a scale
Interval 8.0 to 9.0
|
Adverse Events
Clonidine (Maternal)
Dexmedetomidine (Maternal)
Ropivacaine + Fentanyl (Maternal)
Clonidine (Fetal-neonatal)
Dexmedetomidine (Fetal-neonatal)
Ropivacaine + Fentanyl (Fetal-neonatal)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Clonidine (Maternal)
n=30 participants at risk
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 (Maternal)
n=29 participants at risk
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 (Maternal)
n=29 participants at risk
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
|
Clonidine (Fetal-neonatal)
n=30 participants at risk
Per maternal. Study drug was given during pregnancy while uteroplacental perfusion remained intact. Monitoring for AE/SAE for fetus and infant occurred during labor and delivery (fetal safety monitoring) as well as from day 0 through 3 of life (neonatal safety monitoring).
|
Dexmedetomidine (Fetal-neonatal)
n=29 participants at risk
Per maternal. Study drug was given during pregnancy while uteroplacental perfusion remained intact. Monitoring for AE/SAE for fetus and infant occurred during labor and delivery (fetal safety monitoring) as well as from day 0 through 3 of life (neonatal safety monitoring).
|
Ropivacaine + Fentanyl (Fetal-neonatal)
n=29 participants at risk
Per maternal. Study drug was given during pregnancy while uteroplacental perfusion remained intact. Monitoring for AE/SAE for fetus and infant occurred during labor and delivery (fetal safety monitoring) as well as from day 0 through 3 of life (neonatal safety monitoring).
|
|---|---|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Prolonged Deceleration
|
3.3%
1/30 • Number of events 1 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/29 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/29 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
3.3%
1/30 • Number of events 1 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/29 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/29 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
|
Nervous system disorders
Maternal Nausea
|
10.0%
3/30 • Number of events 3 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
3.4%
1/29 • Number of events 1 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
10.3%
3/29 • Number of events 3 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/30 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/29 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/29 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
|
Nervous system disorders
Maternal Vomiting
|
0.00%
0/30 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/29 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
3.4%
1/29 • Number of events 1 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/30 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/29 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/29 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
|
Nervous system disorders
Maternal Shivering
|
26.7%
8/30 • Number of events 12 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
6.9%
2/29 • Number of events 3 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
6.9%
2/29 • Number of events 3 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/30 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/29 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/29 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
|
Nervous system disorders
Maternal Pruritus
|
3.3%
1/30 • Number of events 1 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/29 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
55.2%
16/29 • Number of events 28 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/30 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/29 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/29 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
|
Nervous system disorders
Maternal Hypotension
|
43.3%
13/30 • Number of events 13 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
34.5%
10/29 • Number of events 10 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
37.9%
11/29 • Number of events 11 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/30 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/29 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
0.00%
0/29 • From enrollment until 3 days after delivery.
Definition of adverse event and/or serious adverse event used to collect adverse event information was per definitions available on clinicaltrials.gov.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place