Comparative use of two local anesthetics in locoregional anesthesia in ambulatory surgery

Comparative study of cloroprocaine versus prilocaine intrathecal anestesia in major ambulatory surgery - Cloroprocaine versus prilocaine in spinal anesthesia

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003972-37-ES

Enrollment

100

Registered

2020-02-28

Start date

2020-06-05

Completion date

Unknown

Last updated

2021-03-08

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

Conditions

Inguinal hernia liable to ambulatory surgery

Interventions

Trade Name: Takipril Product Name: Prilocaine Pharmaceutical Form: Solution for injection INN or Proposed INN: prilokainhyroklorid Other descriptive name: PRILOCAINE HYDROCHLORIDE Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients over 18 years old Inguinal hernia Ambulatory surgery Signed consent 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Allergies to local anesthetics Contraindication to spinal anesthesia Contraindication to ambulatory surgery Pacient refusal

Design outcomes

Primary

Measure	Time frame
Main Objective: % of patients which can stand up theirselves 2 hours after spinal anesthesia (so we can confirm if cloroprocaina has the same qualities of prilocaina in ambulatory surgery);Secondary Objective: % of patients which can stand up theirselves 2,5 hours after spinal anesthesia % of patients which can stand up theirselves 3 hours after spinal anesthesia Time to discharge Time to start feeling pain Number of complications Number of unexpected hospital admissions Number of hospital readmissions Satisfaction of the patient;Primary end point(s): % of patients which can stand up theirselves 2 hours after spinal anesthesia;Timepoint(s) of evaluation of this end point: 2 hours after spinal anesthesia	—

Measure

Time frame

Main Objective: % of patients which can stand up theirselves 2 hours after spinal anesthesia (so we can confirm if cloroprocaina has the same qualities of prilocaina in ambulatory surgery);Secondary Objective: % of patients which can stand up theirselves 2,5 hours after spinal anesthesia % of patients which can stand up theirselves 3 hours after spinal anesthesia Time to discharge Time to start feeling pain Number of complications Number of unexpected hospital admissions Number of hospital readmissions Satisfaction of the patient;Primary end point(s): % of patients which can stand up theirselves 2 hours after spinal anesthesia;Timepoint(s) of evaluation of this end point: 2 hours after spinal anesthesia

—

Secondary

Measure	Time frame
Secondary end point(s): % of patients which can stand up theirselves 2,5 hours after spinal anesthesia % of patients which can stand up theirselves 3 hours after spinal anesthesia Time to discharge Time to start feeling pain Number of complications Number of unexpected hospital admissions Number of hospital readmissions Satisfaction of the patient;Timepoint(s) of evaluation of this end point: 2,5 hours after spinal surgery 3 hours after spinal surgery Before discharge 24 hours after surgery	—

Measure

Time frame

Secondary end point(s): % of patients which can stand up theirselves 2,5 hours after spinal anesthesia % of patients which can stand up theirselves 3 hours after spinal anesthesia Time to discharge Time to start feeling pain Number of complications Number of unexpected hospital admissions Number of hospital readmissions Satisfaction of the patient;Timepoint(s) of evaluation of this end point: 2,5 hours after spinal surgery 3 hours after spinal surgery Before discharge 24 hours after surgery

—

Countries

Spain

Contacts

Public ContactCLVSPR19 Trial Information

Hospital Arnau de Vilanova - Lliria

asensioisabel2@gmail.com

Outcome results

None listed

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