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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003675-11-BE

Enrollment

Registered

2011-08-16

Start date

2011-09-21

Completion date

Unknown

Last updated

2021-03-30

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

Conditions

spinal anesthesia in knee arthroscopy

Interventions

Trade Name: Marcaine Product Name: bupivacaine Pharmaceutical Form: Injection INN or Proposed INN: bupivacaine hydrocloride CAS Number: 18010-40-7 Concentration unit: % percent Concentration type: equ

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: We want to investigate the optimal anesthesia for knee arthroscopy in a day-case setting;Secondary Objective: Secondary end points are: • The ratio between successful and failed blocks • Peroperative anesthesia • Postoperative analgesia • Recovery of sensory and motor block • Voiding times • Discharge times • Incidence of TNS • Hemodynamics: incidence of bradycardia and hypotension ;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. Regression of block will be tested every 15 min postoperatively until comlete recorvery of motor and sensory block.	—

Measure

Time frame

Main Objective: We want to investigate the optimal anesthesia for knee arthroscopy in a day-case setting;Secondary Objective: Secondary end points are: • The ratio between successful and failed blocks • Peroperative anesthesia • Postoperative analgesia • Recovery of sensory and motor block • Voiding times • Discharge times • Incidence of TNS • Hemodynamics: incidence of bradycardia and hypotension ;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. Regression of block will be tested every 15 min postoperatively until comlete recorvery of motor and sensory block.

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary end points are: • The ratio between successful and failed blocks • Peroperative anesthesia • Postoperative analgesia • Recovery of sensory and motor block • Voiding times • Discharge times • Incidence of TNS • Hemodynamics: incidence of bradycardia and hypotension ;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. Incidence of TNS will be recorded at discharge time and 24 hours postoperative (phone call).	—

Measure

Time frame

Secondary end point(s): Secondary end points are: • The ratio between successful and failed blocks • Peroperative anesthesia • Postoperative analgesia • Recovery of sensory and motor block • Voiding times • Discharge times • Incidence of TNS • Hemodynamics: incidence of bradycardia and hypotension ;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. Incidence of TNS will be recorded at discharge time and 24 hours postoperative (phone call).

—

Countries

Belgium

Contacts

Public ContactResearch Anesthesiology

University Hospitals Leuven

christel.huygens@uzleuven.be3216344270

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 12, 2026