Multicenter Study of Chloroprocaine Versus Ropivacaine for Epidural Labor Analgesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-18

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obstetric Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Chloroprocaine group

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

Group Type EXPERIMENTAL

Chloroprocaine

Intervention Type DRUG

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

Ropivacaine group

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

Group Type PLACEBO_COMPARATOR

Chloroprocaine

Intervention Type DRUG

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

Interventions

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Chloroprocaine

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

Intervention Type DRUG

Other Intervention Names

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Ropivacaine

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No