A comparison of chloroprocaine 3% versus levobupivacaine 0.5% for epidural anesthesia during caesarean section.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004918-22-BE

Enrollment

Unknown

Registered

2015-12-22

Start date

2016-06-28

Completion date

Unknown

Last updated

2017-10-09

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

Conditions

anesthetics for women scheduled for elective caesarean section

Interventions

Trade Name: Chirocaine Pharmaceutical Form: Solution for injection INN or Proposed INN: LEVOBUPIVACAINE HYDROCHLORIDE CAS Number: 27262-48-2 Other descriptive name: LEVOBUPIVACAINE HYDROCHLORIDE Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Pregnant patients scheduled for elective caesarean section • =37 weeks of pregnancy • ASA1 • Between 18 and 40 years old • Able to comprehend, sign and date the written informed consent document to participate in the clinical trial Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Pregnancy 115 kg • ASA = 2 • Neurologic disorder • Fetal abnormalities • Twin (or more) pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary hypothesis of this study is that the onset of action for chloroprocaine is more rapid than the onset time for levobupivacaine in elective caesarean section;Secondary Objective: Secondary hypothesis is that the duration of action is less for chloroprocaine vs levobupivacaine.;Primary end point(s): onset time;Timepoint(s) of evaluation of this end point: 0, 2, 5, 10 15, 20, 25 and 30 min	—

Measure

Time frame

Main Objective: The primary hypothesis of this study is that the onset of action for chloroprocaine is more rapid than the onset time for levobupivacaine in elective caesarean section;Secondary Objective: Secondary hypothesis is that the duration of action is less for chloroprocaine vs levobupivacaine.;Primary end point(s): onset time;Timepoint(s) of evaluation of this end point: 0, 2, 5, 10 15, 20, 25 and 30 min

—

Secondary

Measure	Time frame
Secondary end point(s): duration of response;Timepoint(s) of evaluation of this end point: 2, 4 and 24h after surgery	—

Countries

Belgium

Contacts

Public ContactHans De Pla

Bimetra Clinics

bimetra.clinics@uzgent.be+3293320500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026