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Initiation Ropivacaine Dose for Labor Analgesia Via Double Dural Puncture Epidural Technique

NCT07882004 — Not applicable, Not yet recruiting, 30 participants, General Hospital of Ningxia Medical University

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Determination of the Optimal Ropivacaine Dose for Labor Analgesia Initiation Via Double Dural Puncture Epidural Technique: A Sequential Allocation Study

RegistryNCT07882004
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment30 (Estimated)
SponsorGeneral Hospital of Ningxia Medical University (Other)
ConditionsLabor Pain
Interventions0.1% Ropivacaine (Drug)
Datesstart 2026-11-01 (estimated), primary completion 2027-03-30 (estimated), completion 2027-03-30 (estimated), first posted 2026-10-20, last updated 2026-10-20

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Double dural puncture epidural groupExperimentalDrug: 0.1% RopivacaineLabor analgesia via double dural puncture epidural technique
  • 0.1% Ropivacaine (Drug): 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.

+Outcome measures

Primary outcomes

  • The ED₉₀ of ropivacaine [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.

Secondary outcomes

  • Numerical rating scale (NRS) pain score [10, 20, and 30 minutes after initial administration.]: 0-10; 0 = no pain, 10 = unbearable pain
  • Bromage score [30, 60, 120, 180, and 240 minutes after initial administration]: 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
  • APGAR score [1 minute after delivery]: A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
  • APGAR score [5 minutes after delivery]: A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

+Eligibility

Sex: Female, ages: 18 Years to 40 Years

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:

* 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

+Investigators

  • Yi Chen, Principal investigator, General Hospital of Ningxia Medical University

My Notes