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Multicenter Study of Chloroprocaine Versus Ropivacaine for Epidural Labor Analgesia

Efficacy and Safety of Chloroprocaine Versus Ropivacaine for Epidural Labor Analgesia Study: a Randomized, Double-blind, Controlled, Multicenter, Noninferiority Clinical Trial

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06472232
Enrollment
356
Registered
2024-06-25
Start date
2024-06-18
Completion date
2025-09-30
Last updated
2024-06-25

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

Conditions

Obstetric Labor

Keywords

labor analgesia, Chloroprocaine, Ropivacaine

Brief summary

Women requiring epidural labor analgesia were randomized into two groups, one with the local anesthetic chloroprocaine and the other with ropivacaine. The primary outcome was to observe the analgesic scores of the two groups of drugs as well as adverse reactions.

Detailed description

Mothers who met the study criteria vertebrae were included and then divided into two groups. Labor analgesia was provided by epidural anesthesia with a low concentration of local anesthetic (chloroprocaine or ropivacaine) combined with sufentanil. Data related to labor analgesia such as pain scores, motor tissue scores, and body temperature were collected and statistically analyzed to compare the efficacy and adverse effects of the two local anesthetics and to draw conclusions.

Interventions

DRUGChloroprocaine

Selection of low concentration of chloroprocaine as local anesthetic for labor analgesia

Sponsors

Beijing Obstetrics and Gynecology Hospital
CollaboratorOTHER
International Peace Maternity and Child Health Hospital
CollaboratorOTHER
Nanjing Medical University
CollaboratorOTHER
Anhui Women and Children's Medical Center
CollaboratorUNKNOWN
Jiaxing Maternity and Child Health Care Hospital
CollaboratorOTHER
Gansu Maternal and Child Health Center
CollaboratorUNKNOWN
Urumqi Maternal and Child Health Center
CollaboratorUNKNOWN
Shengjing Hospital
CollaboratorOTHER
Zhongnan Hospital
CollaboratorOTHER
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
CollaboratorUNKNOWN
Second Hospital of Jilin University
CollaboratorOTHER
Women's Hospital School Of Medicine Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Primigravid women with full-term pregnancies scheduled for labor analgesia * Determination of labor onset to cervical dilatation ≤ 5cm; * Visual analogue scale (VAS) pain score during contractions \>50 mm (0 mm = no pain at all, 100 mm = most intense pain); * Age ≥20 years; * American Society of Anesthesiologists (ASA) classification II * Body mass index (BMI) between 18.5 and 30 kg/m2 * Height \>155 cm * Signed informed consent.

Exclusion criteria

* Twin or multiple pregnancies * Hypertension * Severe cardiopulmonary and hepatic or renal disease * Severe pregnancy comorbidities such as preeclampsia, eclampsia, HELLP syndrome, placenta praevia, placental abruption, etc. * Cephalopelvic disproportion * History of allergy to local anesthesia * Spinal deformity * Contraindications to intrathecal anesthesia * Refusal to participate in the stud

Design outcomes

Primary

MeasureTime frameDescription
Percentage of effective analgesia30 min after the first epidural addition at the beginning of labor analgesiaPercentage of effective analgesia within 30 min after the first epidural addition at the beginning of labor analgesia in both groups

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026