Comparative doubleblind study with prilocaine 2 % and 2-chloroprocaine for elective caesarean section.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000813-63-BE

Enrollment

Registered

2016-03-08

Start date

2016-04-06

Completion date

Unknown

Last updated

2021-04-05

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

Conditions

Healthy pregnant women undergoing a elective caesarean section with an uncomplicated pregnancy of a singleton, "full-term", all between 18-40 y (ASAI-II) through combined spinal and epidural approach.

Interventions

Trade Name: Ampres Product Name: chloroprocaine hydrochloride Pharmaceutical Form: Solution for injection INN or Proposed INN: CHLOROPROCAINE HYDROCHLORIDE CAS Number: 3858-89-7 Concentration unit: %

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Gender: female • 18-40 years • American Society of Anesthesiologists physical status I - II Indication for elective caesarean section of uncomplicated singleton pregnancy at term (37 weeks or more) 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 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Women who belong to ASA III-IV classification • BMI > 35 • length < 150 cm • foetus with known fetal abnormality • pregnancy less than 37 weeks • (pre) eclampsia • Ever had an allergic reaction to a local anesthetic in the past • Signs of skin infection or inflammation at or near the proposed site of the injection

Design outcomes

Primary

Measure	Time frame
Main Objective: The goal of this trial is to investigate the efficacy of the IMP during caesarean section with and without the use of Sufenta: as well as onset of action and duration of action, the degree of motor block and level of sensory block will be investigated.;Secondary Objective: The secondary objectives are to evualate (dis)comfort (pain scores by Visual Analog Scale 0-10) of the patient (especially during externalisation and internalisation of the uterus), hemodynamics perioperative and possible side effects.;Primary end point(s): Superiority of Tachipri in clinical use for elective caesarean section;Timepoint(s) of evaluation of this end point: Perioperative	—

Measure

Time frame

Main Objective: The goal of this trial is to investigate the efficacy of the IMP during caesarean section with and without the use of Sufenta: as well as onset of action and duration of action, the degree of motor block and level of sensory block will be investigated.;Secondary Objective: The secondary objectives are to evualate (dis)comfort (pain scores by Visual Analog Scale 0-10) of the patient (especially during externalisation and internalisation of the uterus), hemodynamics perioperative and possible side effects.;Primary end point(s): Superiority of Tachipri in clinical use for elective caesarean section;Timepoint(s) of evaluation of this end point: Perioperative

—

Secondary

Measure	Time frame
Secondary end point(s): -VAS scores - Hemodynamics - Side effects;Timepoint(s) of evaluation of this end point: Perioperative	—

Countries

Belgium

Contacts

Public ContactData nurse

Universitair Ziekenhuis Brussel

veerle.vanmossevelde@uzbrussel.be+322+4763134

Outcome results

None listed

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