Trial Outcomes & Findings for Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour (NCT NCT02885350)
NCT ID: NCT02885350
Last Updated: 2021-06-10
Results Overview
All parturients are to have a pain visual analog scale (VAS - on a 0-100 mm scale) at 80mm or higher before the initial study drug delivery. On this scale 0 mm presents a totally pain free condition while 100 mm presents the worst imaginable pain. The change of maximum pain in millimeters on the VAS scale during the 20 minutes following the study drug delivery will be recorded.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
20 minutes
Results posted on
2021-06-10
Participant Flow
Participant milestones
| Measure |
Spinal Fentanyl
20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.
Spinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique
|
Epidural Fentanyl
100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.
Epidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.
|
Spinal Sufentanil
5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.
Spinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique
|
Epidural Sufentanil
20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.
Epidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Spinal Fentanyl
n=20 Participants
20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.
Spinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique
|
Epidural Fentanyl
n=20 Participants
100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.
Epidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.
|
Spinal Sufentanil
n=20 Participants
5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.
Spinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique
|
Epidural Sufentanil
n=20 Participants
20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.
Epidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=80 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
80 Participants
n=80 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=80 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
80 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=80 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Finland
|
20 participants
n=20 Participants
|
20 participants
n=20 Participants
|
20 participants
n=20 Participants
|
20 participants
n=20 Participants
|
80 participants
n=80 Participants
|
|
Pain visual analog scale at 0-100 mm
|
84 mm
STANDARD_DEVIATION 12 • n=20 Participants
|
87 mm
STANDARD_DEVIATION 9 • n=20 Participants
|
86 mm
STANDARD_DEVIATION 8 • n=20 Participants
|
87 mm
STANDARD_DEVIATION 11 • n=20 Participants
|
86 mm
STANDARD_DEVIATION 10 • n=80 Participants
|
PRIMARY outcome
Timeframe: 20 minutesAll parturients are to have a pain visual analog scale (VAS - on a 0-100 mm scale) at 80mm or higher before the initial study drug delivery. On this scale 0 mm presents a totally pain free condition while 100 mm presents the worst imaginable pain. The change of maximum pain in millimeters on the VAS scale during the 20 minutes following the study drug delivery will be recorded.
Outcome measures
| Measure |
Spinal Fentanyl
n=20 Participants
20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.
Spinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique
|
Epidural Fentanyl
n=20 Participants
100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.
Epidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.
|
Spinal Sufentanil
n=20 Participants
5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.
Spinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique
|
Epidural Sufentanil
n=20 Participants
20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.
Epidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.
|
|---|---|---|---|---|
|
Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery
|
60 mm
Interval 46.0 to 74.0
|
36 mm
Interval 24.0 to 47.0
|
67 mm
Interval 54.0 to 81.0
|
42 mm
Interval 30.0 to 55.0
|
SECONDARY outcome
Timeframe: The data below report an average duration of time that is typically less than three hoursThe time from the study drug dose to the administration of next epidural bolus, up to five hours. After the study drug dose all parturients wil have epidural catheters in place for subsequent analgesia.
Outcome measures
| Measure |
Spinal Fentanyl
n=20 Participants
20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.
Spinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique
|
Epidural Fentanyl
n=20 Participants
100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.
Epidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.
|
Spinal Sufentanil
n=20 Participants
5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.
Spinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique
|
Epidural Sufentanil
n=20 Participants
20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.
Epidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.
|
|---|---|---|---|---|
|
The Duration of Labour Analgesia After the Single Dose of Epidural or Intrathecal Opioid
|
177 min
Interval 121.0 to 234.0
|
112 min
Interval 80.0 to 143.0
|
151 min
Interval 111.0 to 192.0
|
130 min
Interval 93.0 to 168.0
|
Adverse Events
Spinal Fentanyl
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Epidural Fentanyl
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Spinal Sufentanil
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Epidural Sufentanil
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Spinal Fentanyl
n=20 participants at risk
20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.
Spinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique
|
Epidural Fentanyl
n=20 participants at risk
100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.
Epidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.
|
Spinal Sufentanil
n=20 participants at risk
5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.
Spinal analgesia for labour pain: Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique
|
Epidural Sufentanil
n=20 participants at risk
20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.
Epidural analgesia for labour pain: Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
90.0%
18/20 • Number of events 18 • 30 minutes
The parturient is monitored for 30 minutes after the intervention
|
40.0%
8/20 • Number of events 8 • 30 minutes
The parturient is monitored for 30 minutes after the intervention
|
60.0%
12/20 • Number of events 12 • 30 minutes
The parturient is monitored for 30 minutes after the intervention
|
40.0%
8/20 • Number of events 8 • 30 minutes
The parturient is monitored for 30 minutes after the intervention
|
Additional Information
Dr Antti Vaananen
Helsinki University Central hospital/Women's hospital/anaesthesia
Phone: 358504271850
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place