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The efficacy of epidural chloroprocaine for relieving breakthrough pain during labour: a prospective randomized, double-blind, controlled study

The efficacy and safety of epidural chloroprocaine for relieving breakthrough pain during labor

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071069
Enrollment
Unknown
Registered
2023-05-04
Start date
2023-05-05
Completion date
Unknown
Last updated
2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

the breakthrough pain of labor analgesia

Interventions

group R:When breakthrough pain occurrs, 6 mL of 0.125% ropivacaine was given by epidural bolus.
group C1:In case of breakthrough pain, 6 mL 0.5% cloprocaine was given by epidural bolus.
group C2:In case of breakthrough pain, 6 mL 1.0% cloprocaine was given by epidural bolus.
group C3:In case of breakthrough pain, 6 mL 1.5% cloprocaine was given by epidural bolus.

Sponsors

Anhui Province Maternity and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 36 Years

Inclusion criteria

Inclusion criteria: 1. After epidural labor analgesia,women who have breakthrough pain; 2. Full term(37 to 41 weeks gestation); 3. Singleton; 4. Aged 20~36 years; 5. BMI 21.0-35.0 kg/m2; 6. American Society of Anesthesiologists physical status II or III.

Exclusion criteria

Exclusion criteria: 1. Contraindications of intraspinal anesthesia; 2. Cephalopelvic disproportion; 3. Abnormal birth canal conditions; 4. Severe pregnancy complications; 5. Fetal malformation or stillbirth; 6. History of chronic pain; 7. History of prenatal use of analgesic, sedative and hypnotic drugs; 8. Mental illness, cognitive dysfunction; 9. Allergic history to opioids, procaine and other esters and amides; 10. Delivery within 1 hour after epidural analgesia.

Design outcomes

Primary

MeasureTime frame
The success rate of treatment of breakthrough pain;Time of onset of investigational drugs to suppress breakthrought pain;

Secondary

MeasureTime frame
Visual Analogue Scale (VAS) score at different time points;Improved Bromage score at different time points;Interval and duration of the first 12 contractions after administration;Number of breakthrough pain;Maternal satisfaction;level of anesthesia;The amount of study drug used to suppress breakthrough pain;Dosage of analgesic pump drugs;The time of the first breakthrough pain;Cervical orifice size at the time of the first breakthrough pain;The salvage treatment rate of 1% lidocaine;Interval between the onset of each two breakthrough pain intervals between each two breakthrough pain;Delivery situation;Neonatal outcome;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactHaijuan Zhu, Tianzhen Ji

Anhui Province Maternity and Child Health Hospital

happy_tianzhen@126.com+86 15256550911

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026