ClinicalTrials.gg
Not yet recruitingNCT07882004Updated Oct 20, 2026

Initiation Ropivacaine Dose for Labor Analgesia Via 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 2026-10-20.

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

Updated Oct 20, 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 dose (ED₉₀) of an initial regimen of 0.1% ropivacaine combined with 0.3 μg/mL sufentanil, administered via the double dural puncture epidural technique for epidural labor analgesia.

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 + 0.3 μg/mL sufentanil, administered via the double dural puncture epidural technique for epidural labor analgesia.

02

Conditions studied

  • Labor Pain

Browse trials for

Keywords

  • Ropivacaine
  • Labor Analgesia
  • Dural Puncture Epidural
03

In context

Labor Pain

409 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 106 studies on the registry; 40 are open to participants now.

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

04

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

  • Singleton full-term pregnant women aged 18 years or above, scheduled to receive epidural labor analgesia;
  • Cervical dilation > 2 cm;
  • Numerical Rating Scale (NRS) pain score > 5;
  • American Society of Anesthesiologists Physical Status Classification II.

Exclusion criteria

Exclusion Criteria:

  • Contraindications to neuraxial analgesia (e.g., coagulation disorders, infection, increased intracranial pressure);
  • Severe pregnancy complications, including hypertensive disorders of pregnancy and diabetes mellitus;
  • Fetal distress;
  • Allergies to local anesthetics or opioids;
  • Receive analgesic pharmacotherapy
05

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 + sufentanil 0.3 µg/mL, 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 VAS score of less than 3 was achieved within 30 minutes after administration.

06

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. Numerical rating scale (NRS) 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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 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
NCT07882004
Responsible party
Sponsor
First posted
Oct 20, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Mar 30, 2027 (estimated)
Completion
Mar 30, 2027 (estimated)
Last update
Oct 20, 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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Ropivacaine

Start the discussion