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Not yet recruitingNCT07894770Updated Oct 26, 2026

The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique

An interventional study of 0.1% Ropivacaine in Labor Pain, sponsored by General Hospital of Ningxia Medical University. Not yet recruiting. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by General Hospital of Ningxia Medical University · Not applicable, Interventional, and Treatment

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Labor Pain

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Keywords

  • Ropivacaine
  • Labor Analgesia
  • Double Dural Puncture Epidural
03

In context

Labor Pain

410 studies on the registry are indexed under Labor Pain; 69 are open to participants now.

This study's planned enrollment of 30 is below the median of 100 across 336 interventional studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

General Hospital of Ningxia Medical University is the lead sponsor of 108 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Double dural puncture epidural group

    Labor analgesia via double dural puncture epidural technique

    Drug: 0.1% Ropivacaine

Interventions

  • 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: When the fetus is delivered

Secondary outcomes

  1. Visual analogue scale pain score

    0-10; 0 = no pain, 10 = unbearable pain

    Time frame: 10, 20, and 30 minutes after initial administration

  2. 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

    Time frame: 30, 60, 120, 180, and 240 minutes after initial administration

  3. APGAR score

    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

    Time frame: 1 minute after delivery

  4. APGAR score

    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

    Time frame: 5 minutes after delivery

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2027; primary completion for Jun 2027, 0 months later.

Of 183 non-industry interventional studies with no phase under Labor Pain, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's planned 0 months is below that.

Counting every sponsor, half of 185 studies reached it within 9 months; a quarter within 5 and three quarters within 14.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2026
First posted
Oct 26, 2026
StartEst.
Jun 30, 2027
Primary completionEst.
Jun 30, 2027
CompletionEst.
Jun 30, 2027
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07894770
Responsible party
Sponsor
First posted
Oct 26, 2026
Start date
Jun 30, 2027 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Oct 26, 2026

Study contacts

Yi Chen
Contact
czzyxgp@163.com
86-951-674-3252
Yi Chen
principal investigator · General Hospital of Ningxia Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ropivacaine

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