Multicenter Study of Chloroprocaine Versus Ropivacaine for Epidural Labor Analgesia

NCT06472232 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: IRB-20240123-R
• Study Type: interventional
• Target: 356
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstetric Labor

Keywords

labor analgesia; Chloroprocaine; Ropivacaine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Chloroprocaine group

EXPERIMENTAL

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

Drug: Chloroprocaine

Ropivacaine group

PLACEBO COMPARATOR

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

Drug: Chloroprocaine

Interventions

Chloroprocaine DRUG

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

Also known as: Ropivacaine

Chloroprocaine group; Ropivacaine group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Interventions

chloroprocaine; Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2024
• First Posted: June 25, 2024
• Study Start: June 18, 2024
• Primary Completion: June 16, 2025
• Study Completion: September 30, 2025
• Last Updated: June 25, 2024

Record last verified: 2024-06