Labor Pain
Conditions
Brief summary
In this study the analgesic effect of two different opioids (fentanyl and sufentanil) will be compared when given either intrathecally or epidurally in primiparous parturients during early phase of the labour.
Interventions
Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique
Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Primiparous parturients * In early phase of labour (cervical dilatation at or under 5 cm) * No prior opioids by any route of administration within past 120 min * Pain at or over 80 mm on 0-100 mm visual analog scale during contraction
Exclusion criteria
* Allergy for any of the medications used * Contraindications for epidural/spinal analgesia * BMI at the time of delivery under 20 or over 35 kg/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery | 20 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Duration of Labour Analgesia After the Single Dose of Epidural or Intrathecal Opioid | The data below report an average duration of time that is typically less than three hours | The 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. |
Countries
Finland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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. | 20 |
| 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 | 20 |
| 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. | 20 |
| Total | 80 |
Baseline characteristics
| Characteristic | Spinal Fentanyl | Epidural Fentanyl | Spinal Sufentanil | Epidural Sufentanil | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 20 Participants | 20 Participants | 80 Participants |
| Pain visual analog scale at 0-100 mm | 84 mm STANDARD_DEVIATION 12 | 87 mm STANDARD_DEVIATION 9 | 86 mm STANDARD_DEVIATION 8 | 87 mm STANDARD_DEVIATION 11 | 86 mm STANDARD_DEVIATION 10 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment Finland | 20 participants | 20 participants | 20 participants | 20 participants | 80 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 20 Participants | 20 Participants | 80 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 18 / 20 | 8 / 20 | 12 / 20 | 8 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery
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.
Time frame: 20 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Spinal Fentanyl | Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery | 60 mm |
| Epidural Fentanyl | Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery | 36 mm |
| Spinal Sufentanil | Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery | 67 mm |
| Epidural Sufentanil | Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery | 42 mm |
Secondary
The Duration of Labour Analgesia After the Single Dose of Epidural or Intrathecal Opioid
The 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.
Time frame: The data below report an average duration of time that is typically less than three hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Spinal Fentanyl | The Duration of Labour Analgesia After the Single Dose of Epidural or Intrathecal Opioid | 177 min |
| Epidural Fentanyl | The Duration of Labour Analgesia After the Single Dose of Epidural or Intrathecal Opioid | 112 min |
| Spinal Sufentanil | The Duration of Labour Analgesia After the Single Dose of Epidural or Intrathecal Opioid | 151 min |
| Epidural Sufentanil | The Duration of Labour Analgesia After the Single Dose of Epidural or Intrathecal Opioid | 130 min |