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The efficacy and safety of different concentrations of chloroprocaine combined with ropivacaine for epidural labor analgesia

EC50 and EC90 of ropivacaine combined with different concentrations of chloroprocaine for epidural labor analgesia: an up-down sequential allocation study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074933
Enrollment
Unknown
Registered
2023-08-21
Start date
2023-08-24
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

Labor analgesia

Interventions

0.0% chloroprocaine group (RP):0.0% chloroprocaine+different concentrations of ropivacaine+sufentanil 0.4 µ g/ml, infusion for 10ml as a bolus first.
0.2% chloroprocaine group (LP0.2):0.2% chloroprocaine+different concentrations of ropivacaine+sufentanil 0.4 µ g/ml, infusion for 10ml as a bolus first.
0.3% chloroprocaine group:0.3% chloroprocaine+different concentrations of ropivacaine+sufentanil 0.4 µ g/ml, infusion for 10ml infusion for 10ml as a bolus first.

Sponsors

Hefei Maternal and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Full term and single primiparous women with ASA grades I-II; 2. Aged 20-35 years; 3. BMI 21-30 kg/m^2; 4. Gestational age 37-41 weeks, all enter the latent period of the first stage of labor (cervical dilation <6 cm), and a visual analogue scale (VAS) pain score exceeding 5 during contractions; 5. All primiparous women voluntarily and knowingly agreed to receive PCEA delivery analgesia.

Exclusion criteria

Exclusion criteria: 1. Contraindications for intraspinal puncture, such as coagulation dysfunction, infection or injury at the puncture site, spinal lesions or severe spinal deformities, neurological diseases or neuropathies; 2. Allergy to local anaesthetics; 3. Multipara, abnormal fetal position, IVF; 4. Severe heart, lung, liver, kidney and other important system diseases; 5. Pathological obstetrics, such as pregnancy complications (high-risk pregnancies such as severe preeclampsia, placental abruption, and placenta previa); 6. Those who cannot undergo vaginal delivery after obstetric evaluation; 7. The inability of pregnant women to cooperate due to combined mental illness or other conditions; 8. Used opioids, tranquilizers, or other analgesics 6 hours or recently before anesthesia; 9. History of allergies to esters, amides, and local anesthetics such as opioids and procaine.

Design outcomes

Primary

MeasureTime frame
The concentration of ropivacaine (EC50 and EC90);

Secondary

MeasureTime frame
The onset of labor analgesia;The rate of breakthrough pain;The rate of perineal distension and pain;Maximum VAS score after analgesia;Average VAS score during analgesia;Times of rescue analgesia;Maternal satisfaction scores;Intensity of uterine contractions (IUCs) ;The thoracic highest sensory level (ice pack method);Motor blockade;Outcomes of delivery, mother and baby ;Analgesic effect;

Countries

China

Contacts

Public ContactHaijuan Zhu

Hospital Maternal and Child Medical Center of Anhui Medical University (Hefei Maternal and Child Health Hospital)

35880762@qq.com+86 139 6677 8885

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026