Labor PainPhase 4NCT04645823
Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor
A Phase 4 study testing Fentanyl Citrate and Lidocaine 1% Injectable Solution in people with Labor Pain and Induced; Birth, run by Women's Hospital HUS at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Labor Pain, Induced; Birth
- What is being tested?
- Fentanyl Citrate and Lidocaine 1% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- 26 Mar 2021to 19 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Labor Pain, Induced; Birth
- Being tested
- Fentanyl Citrate, Lidocaine 1% Injectable Solution
- Keywords
- epidural analgesia, spinal analgesia, labor pain
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl CitrateDrug
Fentanyl citrate 20 µg in 2 ml of saline injected into csf
Lidocaine 1% Injectable SolutionDrug
Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume
Fentanyl CitrateDrug
Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume
| Study group | Role | What they receive |
|---|---|---|
| Spinal fentanyl | Active comparator | 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. Receives: Drug: Fentanyl Citrate |
| Epidural lidocaine and fentanyl | Experimental | 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. Receives: Drug: Lidocaine 1% Injectable Solution; Drug: Fentanyl Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia at 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.
Measured: 20 minutes
Secondary outcomes (7)
Time until pain returns to 60 mm VAS
Time from intervention until the maximum pain during contraction return to 60 mm on VAS scale
Measured: 30-180 minutes
Ambulation during the analgesia provided by the intervention
HAs the parturient been walking during the analgesia provided by the intervention
Measured: 30-180 minutes
Changes in the cardiotocography (fetal heart rate) within 30 minutes after the intervention
Graded as normal, susceptible, pathological
Measured: 0-30 minutes
Pruritus
The incidence of pruritus within 30 minutes after the intervention, graded: none, mild, moderate, severe, unbearable
Measured: 0-30 minutes
SAtisfaction of the parturient with the analgesia provided by the intervention
On 0-100 mm visual analog scale (VAS). Where 0 means no satisfaction at all and 100 mm means maximum satisfaction.
Measured: at 30 minutes
Cervical dilatation rate cm/h during the analgesia intervention
(The cervical dilatation (1-10 cm) 1-3 hours post analgesia - The cervical dilatation (1-5 cm) before analgesia) / time between measurements (hours)
Measured: 0-180 min
Use of oxytocin during the analgesia study period
Oxytocin administered i.v. during 0-30 minutes after the analgesia (yes or no)
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start26 Mar 2021
- Primary completion19 May 2023
- Study completion19 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 60 parturients randomized to two different treatment arms (30 in each group)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's Hospital HUS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antti Vaananen, Women's Hospital HUS
- Investigators
- Antti J Vaananen, MD PhD, Principal investigator, HUCH, Women's hospital/dept of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645823
- Sponsor's protocol ID
- Versio4_22112020
- Other IDs
- 2020-005506-26
- Status last verified
- Apr 2024
- First submitted
- 22 Nov 2020
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salmi L, Jernman R, Vaananen A. Is epidural analgesia non-inferior to intrathecal fentanyl as initiation for neuraxial analgesia in early non-spontaneous labour? Acta Anaesthesiol Scand. 2024 May;68(5):664-674. doi: 10.1111/aas.14389. Epub 2024 Feb 16.
PubMed 38366324
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor
- ClinicalTrials.gov ID
- NCT04645823
- Acronym / sponsor ID
- Versio4_22112020
- Conditions
- Labor Pain, Induced; Birth
- Keywords
- epidural analgesia, spinal analgesia, labor pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Women's Hospital HUSUniversity, hospital or other
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 19 May 2023 (actual)
- Study completion
- 19 May 2023 (actual)
- First posted
- 27 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 60 parturients randomized to two different treatment arms (30 in each group)
| Arm | Type | Receives |
|---|---|---|
| Spinal fentanyl | Active comparator | Drug: Fentanyl CitrateUsing 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. |
| Epidural lidocaine and fentanyl | Experimental | Drug: Lidocaine 1% Injectable Solution, Drug: Fentanyl CitrateUsing 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Signs a consent form to participate voluntarily into the trial
- Induced labor
- singleton pregnancy
- primiparous
- BMI 20-40 at the time of delivery
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl CitrateFentanyl citrate 20 µg in 2 ml of saline injected into csf | Drug | Spinal fentanyl |
| Lidocaine 1% Injectable SolutionFentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume | Drug | Epidural lidocaine and fentanyl |
| Fentanyl CitrateFentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume | Drug | Epidural lidocaine and fentanyl |
Primary outcome
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.
7 secondary outcomes
Time until pain returns to 60 mm VAS
Time frame: 30-180 minutes
Ambulation during the analgesia provided by the intervention
Time frame: 30-180 minutes
Changes in the cardiotocography (fetal heart rate) within 30 minutes after the intervention
Time frame: 0-30 minutes
Pruritus
Time frame: 0-30 minutes
SAtisfaction of the parturient with the analgesia provided by the intervention
Time frame: at 30 minutes
Cervical dilatation rate cm/h during the analgesia intervention
Time frame: 0-180 min
Use of oxytocin during the analgesia study period
Time frame: 30 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Background: PubMed 38366324Salmi L, Jernman R, Vaananen A. Is epidural analgesia non-inferior to intrathecal fentanyl as initiation for neuraxial analgesia in early non-spontaneous labour? Acta Anaesthesiol Scand. 2024 May;68(5):664-674. doi: 10.1111/aas.14389. Epub 2024 Feb 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antti J Vaananen, MD PhD principal investigator
HUCH, Women's hospital/dept of anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl Citrate and Lidocaine 1% Injectable Solution in people with Labor Pain and Induced; Birth, run by Women's Hospital HUS at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesia at 20 minutes (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04645823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.