Multicenter Study of Chloroprocaine Versus Ropivacaine for Epidural Labor Analgesia

Women's Hospital School Of Medicine Zhejiang University

Status and phase: Not yet enrolling; Phase 4

Conditions: Obstetric Labor

Treatments: Drug: Chloroprocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06472232

IRB-20240123-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 356 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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356 participants in 2 patient groups, including a placebo group

Chloroprocaine group

Experimental group

Description:

Selection of local anesthetics for epidural labor analgesia with low concentration of chloroprocaine combined with sufentanil

Treatment:

Drug: Chloroprocaine

Ropivacaine group

Placebo Comparator group

Description:

Selection of local anesthetics for epidural labor analgesia with low concentration of ropivacaine combined with sufentanil

Treatment:

Drug: Chloroprocaine