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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

88 participants

Primary outcome timeframe

First 30 minutes of analgesia

Results posted on

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

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

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 analgesia

Population: 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

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 analgesia

Population: 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

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 analgesia

Population: 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

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 analgesia

Population: 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

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 delivery

Population: 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

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 delivery

Population: 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

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 administration

Population: Maternal only

This is measured as any hypotensive event occurring any time between 0-120 min after study drug administration.

Outcome measures

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 administration

Population: Maternal only

Patient self-report of nausea at any time between 0-120 min after study drug administration

Outcome measures

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 administration

Population: Maternal only

Patient self-report of vomiting at any time between 0-120 min after study drug administration

Outcome measures

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 administration

Population: Maternal only

Patient self-report of shivering at any time between 0-120 min after study drug administration

Outcome measures

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 administration

Population: Maternal only

Patient self-report of pruritus at any time between 0-120 min after study drug administration

Outcome measures

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 delivery

Population: Maternal only

Patient self-report regarding satisfaction with analgesia on a scale of 1-10; 1 = not satisfied, 10 = the most satisfied.

Outcome measures

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 delivery

Population: 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

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)

Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths

Dexmedetomidine (Maternal)

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Ropivacaine + Fentanyl (Maternal)

Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths

Clonidine (Fetal-neonatal)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Dexmedetomidine (Fetal-neonatal)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Ropivacaine + Fentanyl (Fetal-neonatal)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Dr. Grace Lim, MD, MSc

UPMC Magee Women's Hospital

Phone: 412-641-1778

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place