Labor PainNCT07894770
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
A study testing 0.1% Ropivacaine in people with Labor Pain, run by General Hospital of Ningxia Medical University.
Trial summary
This study aims to determine the 90% effective initial volume of 0.1% ropivacaine for labor analgesia under the double dural puncture epidural technique Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- 0.1% Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2027to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-45 years
- Singleton pregnancy at 37-42 weeks of gestation
- Scheduled for epidural labor analgesia
- Cervical dilation <5 cm
- Visual analogue scale pain score ≥ 6
- American Society of Anesthesiologists physical status II.
Who cannot join
- Contraindications to neuraxial anesthesia
- Severe pregnancy comorbidities (e.g., diabetes, cardiovascular or cerebrovascular disease)
- Inability to cooperate with visual analogue scale pain score assessment
- Contraindications to ropivacaine
- Use of opioid analgesics before analgesia.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The 90% Effective Initial Volume of 0.1% Ropivacaine for Labor Analgesia Under Double Dural Puncture Epidural Technique: A Sequential Allocation Study
This study aims to determine the 90% effective initial volume of 0.1% ropivacaine for labor analgesia under the double dural puncture epidural technique
Read the detailed description
Epidural labor analgesia is a widely adopted pain management modality for parturition. Recent technical advances including the dural puncture epidural (DPE) technique have considerably improved the quality of the childbirth experience. The double dural puncture epidural technique appears to improve this effect more effectively. This study aims to determine the 90% effective dose (ED₉₀) of an initial regimen of 0.1% ropivacaine, administered via the double dural puncture epidural technique for epidural labor analgesia.
- Conditions
- Labor Pain
- Being tested
- 0.1% Ropivacaine
- Keywords
- Ropivacaine, Labor Analgesia, Double Dural Puncture Epidural
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1% RopivacaineDrug
An initial bolus of 0.1% ropivacaine , with a total volume of 10 mL (containing 10 mg ropivacaine), was administered to the first patient. For subsequent patients, the dose was adjusted in increments or decrements of 2 mL (2 mg 0.1% ropivacaine), based on whether a visual analogue scale pain score of less than 3 was achieved within 30 minutes after administration.
| Study group | Role | What they receive |
|---|---|---|
| Double dural puncture epidural group | Experimental | Labor analgesia via double dural puncture epidural technique Receives: Drug: 0.1% Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ED₉₀ of ropivacaine
The ED₉₀ of ropivacaine required for parturients to achieve an numerical rating scale (NRS) pain score <3 within 30 minutes following the initial administration.
Measured: When the fetus is delivered
Secondary outcomes (4)
Visual analogue scale pain score
0-10; 0 = no pain, 10 = unbearable pain
Measured: 10, 20, and 30 minutes after initial administration
Bromage score
0: full flexion of knees and ankles; 1: partial knee flexion with full ankle flexion; 2: inability to flex knees with partial ankle flexion; 3: inability to flex knees or ankles
Measured: 30, 60, 120, 180, and 240 minutes after initial administration
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Measured: 1 minute after delivery
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Measured: 5 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start30 Jun 2027 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Chen, Principal investigator, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894770
- Sponsor's protocol ID
- Yi Chen-2026-2
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 90% Effective Initial Volume of 0.1% Ropivacaine for Labor Analgesia Under Double Dural Puncture Epidural Technique: A Sequential Allocation Study
- ClinicalTrials.gov ID
- NCT07894770
- Acronym / sponsor ID
- Yi Chen-2026-2
- Conditions
- Labor Pain
- Keywords
- Ropivacaine, Labor Analgesia, Double Dural Puncture Epidural
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 30 Jun 2027 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 Oct 2026 (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.
This study aims to determine the 90% effective initial volume of 0.1% ropivacaine for labor analgesia under the double dural puncture epidural technique
Detailed description
Epidural labor analgesia is a widely adopted pain management modality for parturition. Recent technical advances including the dural puncture epidural (DPE) technique have considerably improved the quality of the childbirth experience. The double dural puncture epidural technique appears to improve this effect more effectively. This study aims to determine the 90% effective dose (ED₉₀) of an initial regimen of 0.1% ropivacaine, administered via the double dural puncture epidural technique for epidural labor analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Double dural puncture epidural group | Experimental | Drug: 0.1% RopivacaineLabor analgesia via double dural puncture epidural technique |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-45 years
- Singleton pregnancy at 37-42 weeks of gestation
- Scheduled for epidural labor analgesia
- Cervical dilation <5 cm
- Visual analogue scale pain score ≥ 6
Key exclusion criteria (5 listed)
- Contraindications to neuraxial anesthesia
- Severe pregnancy comorbidities (e.g., diabetes, cardiovascular or cerebrovascular disease)
- Inability to cooperate with visual analogue scale pain score assessment
- Contraindications to ropivacaine
- Use of opioid analgesics before analgesia.
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 |
|---|---|---|
| 0.1% RopivacaineAn initial bolus of 0.1% ropivacaine , with a total volume of 10 mL (containing 10 mg ropivacaine), was administered to the first patient. For subsequent patients, the dose was adjusted in increments or decrements of 2 mL (2 mg 0.1% ropivacaine), based on whether a visual analogue scale pain score of less than 3 was achieved within 30 minutes after administration. | Drug | Double dural puncture epidural group |
Primary outcome
The ED₉₀ of ropivacaine
Time frame: When the fetus is delivered
The ED₉₀ of ropivacaine required for parturients to achieve an numerical rating scale (NRS) pain score <3 within 30 minutes following the initial administration.
4 secondary outcomes
Visual analogue scale pain score
Time frame: 10, 20, and 30 minutes after initial administration
Bromage score
Time frame: 30, 60, 120, 180, and 240 minutes after initial administration
APGAR score
Time frame: 1 minute after delivery
APGAR score
Time frame: 5 minutes after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- 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.
Yi Chen principal investigator
General Hospital of Ningxia Medical University
Questions about this trial
What is this clinical trial studying?
A study testing 0.1% Ropivacaine in people with Labor Pain, run by General Hospital of Ningxia Medical University.
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 6 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: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Chen (86-951-674-3252, czzyxgp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ED₉₀ of ropivacaine (time frame: When the fetus is delivered). 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 26 Oct 2026.