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Clinical efficacy of ultra-low concentration local anesthetic in double-hole dural puncture epidural analgesia combined with doula companionship: A prospective randomized controlled trial

Clinical efficacy of ultra-low concentration local anesthetic in double-hole dural puncture epidural analgesia combined with doula companionship: A prospective randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128427
Enrollment
Unknown
Registered
2026-07-20
Start date
2026-07-20
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Doulas' accompaniment combined with labor pain relief techniques

Interventions

control group :0.1% Ropivacaine epidural analgesia
the study group:The labor assistant accompanied and combined 0.06% ropivacaine for bilateral spinal puncture epidural analgesia.

Sponsors

Dalian Women and Children’s Medical Group
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Primiparas with ASA classification I-II; 2. Gestational age 37-42 weeks, single fetus in cephalic presentation, natural labor onset; 3. Cervical dilation of 2-3 cm, visual analogue scale (VAS) score >= 40 mm; 4. Age 18-40 years; 5. Voluntary participation and signing of informed consent form.

Exclusion criteria

Exclusion criteria: 1. Contraindications to intrathecal anesthesia (coagulation disorders, spinal deformities, severe hypovolemia, local anesthetic hypersensitivity); 2. Administration of opioids or sedative medications within four hours prior to delivery; 3. High-risk pregnancy (preeclampsia, placenta previa, gestational diabetes mellitus, etc.); 4. BMI exceeding 40 kg/m² or estimated fetal weight >= 4000g (with ultrasound indications of BPD >= 100mm, HC >= 350mm); 5. Refusal to participate, presence of communication barriers, or history of psychiatric disorders; 6. Accidental dural puncture during epidural catheterization or delivery occurring within one hour after catheter placement.

Design outcomes

Primary

MeasureTime frame
The timing of the first episode of severe pain after the administration of labor analgesia;Total consumption of ropivacaine;Patient satisfaction;

Secondary

MeasureTime frame
The onset time of labor pain relief;Observe the Feeling of Anal Distension in Parturients;Duration of active period (min);Duration of second stage of labor (min);Forceps delivery;Postpartum hemorrhage;Nausea, Vomiting;skin Itch;intrapartum fever;Incidence Rate of Urinary Retention 8 Hours after Delivery;Incidence Rate of Headache 48 Hours after Delivery;1-min Apgar score;5-min Apgar score;Bromage score;The incubation period;Sensory Nerve block;

Countries

China

Contacts

Public ContactJin Meihua

Dalian Women and Children’s Medical Group

2856750721@qq.com+86 180 9885 7078

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026