Comparisson of two epidural drugs in day-case surgery

Chloroprocaine vs prilocaine for spinal anaesthesia in day-case surgery: a double-blind randomized trial - Chloroprocaine vs prilocaine in day case surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001944-13-NL

Enrollment

175

Registered

2016-02-29

Start date

2016-07-27

Completion date

Unknown

Last updated

2018-08-20

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

Conditions

Patients scheduled for ambulatory knee arthroscopy surgery receive one of the two spinal anaesthetics

Interventions

Trade Name: Prilotekal Pharmaceutical Form: Solution for injection Trade Name: Ampres Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Scheduled ambulatory knee arthroscopy - Age = 18 years - ASA physical status I- II 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 175 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Allergy to one of the study drugs - Contraindication to neuraxial anaesthesia - Previous neuropathy to the lower extremities - Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate effectiveness of spinal chloroprocaine, and prilocaine in day case surgery. The null hypothesis is that there is no significant intergroup difference in time to complete recovery from motor blockade. ;Secondary Objective: adverse events, time to ambulation and patient satisfaction;Primary end point(s): time to complete motor block recovery;Timepoint(s) of evaluation of this end point: Motor blockade is evaluated at 5, 10, 15, 20, 25 and 30 min and then every 15 min until both legs can be fully elevated	—

Measure

Time frame

Main Objective: To investigate effectiveness of spinal chloroprocaine, and prilocaine in day case surgery. The null hypothesis is that there is no significant intergroup difference in time to complete recovery from motor blockade. ;Secondary Objective: adverse events, time to ambulation and patient satisfaction;Primary end point(s): time to complete motor block recovery;Timepoint(s) of evaluation of this end point: Motor blockade is evaluated at 5, 10, 15, 20, 25 and 30 min and then every 15 min until both legs can be fully elevated

—

Secondary

Measure	Time frame
Secondary end point(s): urine retention needing catheterisation and Transient Neurologic Syndrom (TNS);Timepoint(s) of evaluation of this end point: 60 min, 1 day and 7 days after surgery	—

Countries

Netherlands

Contacts

Public ContactClinical trials information

Zaans Medisch Centrum

apotheek@zaansmc.nl

Outcome results

None listed

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