- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04645823
Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor
August 28, 2023 updated by: Antti Vaananen, Women's Hospital HUS
A total of 60 parturients undergoing induction of labour will be consented to participate in the study where they will be randomized to receive either spinal fentanyl (20 µg) or epidural analgesia (fentanyl 100µg and lidocaine 80 mg).
They will be monitored for the development of analgesia for a duration of 30 minutes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Helsinki, Finland, 00029
- HUS/Women's hospital dept of anaesthesia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Signs a consent form to participate voluntarily into the trial
- Induced labor
- singleton pregnancy
- primiparous
- BMI 20-40 at the time of delivery
- No history of allergy for lidocaine or fentanyl
- sufficient command of Finnish language to understand the consent form and interview
- Cervical dilatation at maximum 4 cm at the time of intervention
Exclusion Criteria:
- Any contraindication for spinal or epidural analgesia
- Allergy for lidocaine or fentanyl
- The patient has received any opioid medication within 90 minutes prior to intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Spinal fentanyl
Using a combined spinal epidural technique a single dose of 20 µg of fentanyl diluted into 2 ml with NaCl 0.9 % will be injected into the CSF at lower lumbar interspace.
An epidural catheter is left in place for subsequent analgesic doses.
|
Fentanyl citrate 20 µg in 2 ml of saline injected into csf
Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume
|
Experimental: Epidural lidocaine and fentanyl
Using a catheter in the epidural space in the lower lumbar interspace a single dose of lidocaine (80 mg) and fentanyl (100 µg) is given.
The epidural catheter is left in place for subsequent analgesic doses.
|
Fentanyl citrate 20 µg in 2 ml of saline injected into csf
Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume
Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analgesia at 20 minutes
Time Frame: 20 minutes
|
Reduction of visual analog scale (VAS) pain during contraction from pre-intervention value.
0 mm means no pain while 100 mm means worst possible pain.
|
20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time until pain returns to 60 mm VAS
Time Frame: 30-180 minutes
|
Time from intervention until the maximum pain during contraction return to 60 mm on VAS scale
|
30-180 minutes
|
Ambulation during the analgesia provided by the intervention
Time Frame: 30-180 minutes
|
HAs the parturient been walking during the analgesia provided by the intervention
|
30-180 minutes
|
SAtisfaction of the parturient with the analgesia provided by the intervention
Time Frame: at 30 minutes
|
On 0-100 mm visual analog scale (VAS).
Where 0 means no satisfaction at all and 100 mm means maximum satisfaction.
|
at 30 minutes
|
Changes in the cardiotocography (fetal heart rate) within 30 minutes after the intervention
Time Frame: 0-30 minutes
|
Graded as normal, susceptible, pathological
|
0-30 minutes
|
Pruritus
Time Frame: 0-30 minutes
|
The incidence of pruritus within 30 minutes after the intervention, graded: none, mild, moderate, severe, unbearable
|
0-30 minutes
|
Cervical dilatation rate cm/h during the analgesia intervention
Time Frame: 0-180 min
|
(The cervical dilatation (1-10 cm) 1-3 h post analgesia - The cervical dilatation (1-5 cm) before analgesia) / time between measurements (h)
|
0-180 min
|
Use of oxytocin during the analgesia study period
Time Frame: 30 min
|
Oxytocin administered i.v.
during 0-30 min after the analgesia (yes or no)
|
30 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Antti J Vaananen, MD PhD, HUCH, Women's hospital/dept of anesthesia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 26, 2021
Primary Completion (Actual)
May 19, 2023
Study Completion (Actual)
May 19, 2023
Study Registration Dates
First Submitted
November 22, 2020
First Submitted That Met QC Criteria
November 22, 2020
First Posted (Actual)
November 27, 2020
Study Record Updates
Last Update Posted (Actual)
August 30, 2023
Last Update Submitted That Met QC Criteria
August 28, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Labor Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Membrane Transport Modulators
- Adjuvants, Anesthesia
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Anticoagulants
- Chelating Agents
- Sequestering Agents
- Calcium Chelating Agents
- Fentanyl
- Lidocaine
- Citric Acid
- Sodium Citrate
Other Study ID Numbers
- Versio4_22112020
- 2020-005506-26 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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