Optimal dose of epidural drug in day-case surgery

ED50 and ED90 of intrathecal 1% chloroprocaine in day-case knee arthroscopy - CORONA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002559-27-NL

Enrollment

Registered

2018-01-10

Start date

2018-03-29

Completion date

Unknown

Last updated

2024-12-09

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 intrathecal chloroprocaine

Interventions

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-III 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) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Allergy to chloroprocaine Contraindication to neuraxial anaesthesia Previous neuropathy to the lower extremities Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the effective dose (ED)50 and the ED90 of Chloroprocaine for patients undergoing knee arthroscopy. ;Secondary Objective: Adverse events, patiënt satisfaction;Primary end point(s): Successful anesthesia: 1. Complete loss of cold sensation at the L2 dermatome, AND 2. Pain is 0-2 following inflation of the tourniquet and zero upon incision ;Timepoint(s) of evaluation of this end point: 1. Ice cubes are used to follow sensory block at t=2, 4, 6, 8, 10, 15, 20, 25 and 30 min, and then at 15-min intervals until the sensory blockade had regressed tot dermatome S2. 2. Pain is evaluated at inflation of the tourniquet and just before incision	—

Measure

Time frame

Main Objective: To determine the effective dose (ED)50 and the ED90 of Chloroprocaine for patients undergoing knee arthroscopy. ;Secondary Objective: Adverse events, patiënt satisfaction;Primary end point(s): Successful anesthesia: 1. Complete loss of cold sensation at the L2 dermatome, AND 2. Pain is 0-2 following inflation of the tourniquet and zero upon incision ;Timepoint(s) of evaluation of this end point: 1. Ice cubes are used to follow sensory block at t=2, 4, 6, 8, 10, 15, 20, 25 and 30 min, and then at 15-min intervals until the sensory blockade had regressed tot dermatome S2. 2. Pain is evaluated at inflation of the tourniquet and just before incision

—

Secondary

Measure	Time frame
Secondary end point(s): 1. On-set and off-set time motor block 2. Urine retention needing catheterisation 3. Transient Neurologic Syndrom (TNS) 4. Time to ambulation/hospital discharge 5. Patient satisfaction;Timepoint(s) of evaluation of this end point: 1. Motor blockade is evaluated at 5, 10, 15, 20, 25 and 30 min after intrathecal administration of the study drug, and then every 15 min until both legs can be fully elevated 2. a bladder scan is performed 30 minutes after surgery 3+5. At day 1 and 7 postoperatively, patients are interviewed by telephone 4. Day of surgery	—

Measure

Time frame

Secondary end point(s): 1. On-set and off-set time motor block 2. Urine retention needing catheterisation 3. Transient Neurologic Syndrom (TNS) 4. Time to ambulation/hospital discharge 5. Patient satisfaction;Timepoint(s) of evaluation of this end point: 1. Motor blockade is evaluated at 5, 10, 15, 20, 25 and 30 min after intrathecal administration of the study drug, and then every 15 min until both legs can be fully elevated 2. a bladder scan is performed 30 minutes after surgery 3+5. At day 1 and 7 postoperatively, patients are interviewed by telephone 4. Day of surgery

—

Countries

Netherlands

Contacts

Public Contactclinical trial information

Zaans Medisch Centrum

apotheek@zaansmc.nl

Outcome results

None listed

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