Comparison of 2-chloroprocaïne, bupivacaïne and lidocaïne for spinal anesthesia in knee artroscopy in an outpatient setting: a double blind randomised trial

Phase 1

• Conditions: spinal anesthesia in knee arthroscopy; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2011-003675-11-BE
• Lead Sponsor: niversity Hospitals Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-16
• Study Completion: 2014-05-30
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

Male and female patients = 18 years old;
scheduled to undergo elective knee arthroscopy
ASA I,II and 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 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients who take anti -depressants or/and anti-psychotics;
•Allergies to local anaesthetics;
•ASA IV.
•Known prostate hypertrophy (risk for urinary retention).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: We want to investigate the optimal anesthesia for knee arthroscopy in a day-case setting;Secondary Objective: Secondary end points are:<br>•The ratio between successful and failed blocks<br>•Peroperative anesthesia<br>•Postoperative analgesia<br>•Recovery of sensory and motor block<br>•Voiding times<br>•Discharge times<br>•Incidence of TNS<br>•Hemodynamics: incidence of bradycardia and hypotension<br>;Primary end point(s): The primary study end point is to investigate which local anesthestic has the shortest time to ambulation defined as the complete recovery of motor and sensory block.;Timepoint(s) of evaluation of this end point: Onset time of sensory and motor block: the level of the block will be tested 5, 10 and 15 min after injection of the local anaesthetic.<br>Regression of block will be tested every 15 min postoperatively until comlete recorvery of motor and sensory block.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary end points are:<br>•The ratio between successful and failed blocks<br>•Peroperative anesthesia<br>•Postoperative analgesia<br>•Recovery of sensory and motor block<br>•Voiding times<br>•Discharge times<br>•Incidence of TNS<br>•Hemodynamics: incidence of bradycardia and hypotension<br><br>;Timepoint(s) of evaluation of this end point: (Hemodynamic) parameters will be recorded every 5 minutes until the end of surgery, every 15 minutes the first hour postoperative and then every hour until discharge.<br>Incidence of TNS will be recorded at discharge time and 24 hours postoperative (phone call).