Multicenter Study of Chloroprocaine Versus Ropivacaine for Epidural Labor Analgesia
- Registration Number
- NCT06472232
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 356
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chloroprocaine group Chloroprocaine Selection of local anesthetics for epidural labor analgesia with low concentration of chloroprocaine combined with sufentanil Ropivacaine group Chloroprocaine Selection of local anesthetics for epidural labor analgesia with low concentration of ropivacaine combined with sufentanil
- Primary Outcome Measures
Name Time Method Percentage of effective analgesia 30 min after the first epidural addition at the beginning of labor analgesia Percentage of effective analgesia within 30 min after the first epidural addition at the beginning of labor analgesia in both groups
- Secondary Outcome Measures
Name Time Method