Labor PainNCT07882004
Initiation Ropivacaine Dose for Labor Analgesia Via 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 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 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
- 1 Nov 2026to 30 Mar 2027
- Phase
- Interventional
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
- 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.
Who cannot join
- 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
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: Determination of the Optimal Ropivacaine Dose for Labor Analgesia Initiation Via Double Dural Puncture Epidural Technique: A Sequential Allocation Study
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.
- Conditions
- Labor Pain
- Being tested
- 0.1% Ropivacaine
- Keywords
- Ropivacaine, Labor Analgesia, 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 + 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.
| 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)
Numerical rating scale (NRS) 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 posted20 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 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
- NCT07882004
- Sponsor's protocol ID
- Yi Chen-2026-1
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No