Labor PainNCT04290702
Comparison of Epidural, Combined and Dural Puncture Labor Epidural on Pain, and Course of Vaginal Delivery
A study testing regional analgesia for labor in people with Labor Pain and Analgesia, run by University of Athens at 2 sites in Greece.
Trial summary
The three standard techniques used for labor analgesia, thus epidural, combined spinal-epidural and dural puncture epidural will be compared regarding their impact on pain intensity, analgesic and local anesthetic consumption and course of vaginal delivery in a prospective, randomised, double blind manner Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Labor Pain, Analgesia
- What is being tested?
- regional analgesia for labor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesGreece
- Study dates
- 26 Feb 2020to Dec 2021
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- parturients requiring regional labor analgesia
- dilation less than 5cm
Who cannot join
- contraindication for regional technique
- refuse to participate
- language barriers
- obesity
- no pain
Trial locations and contacts
2 sites in 1 country.
Greece2 sites, 2 recruiting
- Recruiting
Aretaieio Hospital, University of Athens
Athens, Attica, 11528
Chryssoula V Staikou, MD, +210 7286172, c_staikou@yahoo.gr
Chryssoula V Staikou, MD, DESA
- Recruiting
Aretaieio Hospital
Athens
Chryssoula V Staikou, Assoc Prof
About this study
Official title: The Effect of Epidural, Combined and Dural Puncture Labor Epidural on Pain, Analgesics and Course of Vaginal Delivery: Randomised, Double Blind Study
The three standard techniques used for labor analgesia, thus epidural, combined spinal-epidural and dural puncture epidural will be compared regarding their impact on pain intensity, analgesic and local anesthetic consumption and course of vaginal delivery in a prospective, randomised, double blind manner
- Conditions
- Labor Pain, Analgesia
- Being tested
- regional analgesia for labor
- Medical subject headings
- Labor Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional analgesia for laborProcedure or surgery
three commonly used regional analgesic techniques are used, with local anesthetic ropivacaine, opioid fentanyl, parturient controlled epidural analgesia
| Study group | Role | What they receive |
|---|---|---|
| epidural | Active comparator | Not described Receives: Procedure: regional analgesia for labor |
| combined | Active comparator | Not described Receives: Procedure: regional analgesia for labor |
| dural puncture epidural | Active comparator | Not described Receives: Procedure: regional analgesia for labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesic consumption
the amount of local anesthetic and opioid that required during labor
Measured: during the procedure/delivery
Secondary outcomes (3)
pain intensity on a numerical rating scale (minimum=0, maximum=10)
pain intensity
Measured: during the procedure/delivery
duration of labor
duration of first stage
Measured: until delivery
satisfaction on a numerical rating scale (minimum=0, maximum=10)
satisfaction of parturients
Measured: during the procedure/delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start26 Feb 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups with different regional analgesic technique
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Staikou Chryssoula, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290702
- Sponsor's protocol ID
- 155/19-12-19
- Status last verified
- Mar 2020
- First submitted
- 19 Jan 2020
- Last updated
- 5 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Epidural, Combined and Dural Puncture Labor Epidural on Pain, Analgesics and Course of Vaginal Delivery: Randomised, Double Blind Study
- ClinicalTrials.gov ID
- NCT04290702
- Acronym / sponsor ID
- 155/19-12-19
- Conditions
- Labor Pain, Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 2 Mar 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.
The three standard techniques used for labor analgesia, thus epidural, combined spinal-epidural and dural puncture epidural will be compared regarding their impact on pain intensity, analgesic and local anesthetic consumption and course of vaginal delivery in a prospective, randomised, double blind manner
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 groups with different regional analgesic technique
| Arm | Type | Receives |
|---|---|---|
| epidural | Active comparator | Procedure: regional analgesia for labor |
| combined | Active comparator | Procedure: regional analgesia for labor |
| dural puncture epidural | Active comparator | Procedure: regional analgesia for labor |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- parturients requiring regional labor analgesia
- dilation less than 5cm
Key exclusion criteria (5 listed)
- contraindication for regional technique
- refuse to participate
- language barriers
- obesity
- no pain
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 |
|---|---|---|
| regional analgesia for laborthree commonly used regional analgesic techniques are used, with local anesthetic ropivacaine, opioid fentanyl, parturient controlled epidural analgesia | Procedure or surgery | combined, dural puncture epidural, epidural |
Primary outcome
analgesic consumption
Time frame: during the procedure/delivery
the amount of local anesthetic and opioid that required during labor
3 secondary outcomes
pain intensity on a numerical rating scale (minimum=0, maximum=10)
Time frame: during the procedure/delivery
duration of labor
Time frame: until delivery
satisfaction on a numerical rating scale (minimum=0, maximum=10)
Time frame: during the procedure/delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regional analgesia for labor in people with Labor Pain and Analgesia, run by University of Athens at 2 sites in Greece.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chyrssoula Staikou, Assoc Prof (00302107780172, c_staikou@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analgesic consumption (time frame: during the procedure/delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2020.