Optimal dose of epidural drug in day-case surgery

Phase 1

Conditions: Patients scheduled for ambulatory knee arthroscopy surgery receive intrathecal chloroprocaine
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2017-002559-27-NL

Lead Sponsor: Zaans Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 90

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>1. Complete loss of cold sensation at the L2 dermatome, AND<br>2. Pain is 0-2 following inflation of the tourniquet and zero upon incision <br>;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. <br><br>2. Pain is evaluated at inflation of the tourniquet and just before incision

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. On-set and off-set time motor block<br>2. Urine retention needing catheterisation <br>3. Transient Neurologic Syndrom (TNS) <br>4. Time to ambulation/hospital discharge<br>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<br>2. a bladder scan is performed 30 minutes after surgery<br>3+5. At day 1 and 7 postoperatively, patients are interviewed by telephone<br>4. Day of surgery<br>