Clinical trial NCT06472232: Multicenter Study of Chloroprocaine Versus Ropivacaine for Epidural Labor Analgesia
Official title: Efficacy and Safety of Chloroprocaine Versus Ropivacaine for Epidural Labor Analgesia Study: a Randomized, Double-blind, Controlled, Multicenter, Noninferiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Obstetric Labor
Keywords: labor analgesia
Chloroprocaine
Ropivacaine
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
Collaborators: name: Beijing Obstetrics and Gynecology Hospital
name: International Peace Maternity and Child Health Hospital
name: Nanjing Medical University
name: Anhui Women and Children's Medical Center
name: Jiaxing Maternity and Child Health Care Hospital
name: Gansu Maternal and Child Health Center
name: Urumqi Maternal and Child Health Center
name: Shengjing Hospital
name: Zhongnan Hospital
name: The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
name: The Second Norman Bethune Hospital of Jilin University
First posted: 2024-06-25
Enrollment: 356
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of effective analgesia
timeFrame: 30 min after the first epidural addition at the beginning of labor analgesia
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: