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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstetric Labor
• Intervention / Treatment: Drug: Chloroprocaine

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.

• Study Type: Interventional
• Enrollment (Estimated): 356
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chloroprocaine group; Selection of local anesthetics for epidural labor analgesia with low concentration of chloroprocaine combined with sufentanil	Drug: Chloroprocaine; Selection of low concentration of chloroprocaine as local anesthetic for labor analgesia; Other Names: Ropivacaine
Placebo Comparator: Ropivacaine group; Selection of local anesthetics for epidural labor analgesia with low concentration of ropivacaine combined with sufentanil	Drug: Chloroprocaine; Selection of low concentration of chloroprocaine as local anesthetic for labor analgesia; Other Names: Ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of effective analgesia	Percentage of effective analgesia within 30 min after the first epidural addition at the beginning of labor analgesia in both groups	30 min after the first epidural addition at the beginning of labor analgesia

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Collaborators: Shengjing Hospital; Jiaxing Maternity and Child Health Care Hospital; Beijing Obstetrics and Gynecology Hospital; International Peace Maternity and Child Health Hospital; Women's Hospital of Nanjing Medical University; The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University; The Second Norman Bethune Hospital of Jilin University; Zhongnan Hospital of Wuhan University; Anhui Women and Children's Medical Center; Gansu Maternal and Child Health Center; Urumqi Maternal and Child Health Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 18, 2024
• Primary Completion (Estimated): June 16, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: June 16, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Ropivacaine; labor analgesia; Chloroprocaine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine; Chloroprocaine
• Other Study ID Numbers: IRB-20240123-R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No