Comparison of Hyperbaric Prilocaine With Chloroprocaine for Intrathecal Anaesthesia in Day Case Knee Arthroscopy

Centre Hospitalier Universitaire Saint Pierre80 enrolled

Overview

This study compares intrathecal 1% plain chloroprocaine with intrathecal 2% hyperbaric prilocaine for patients undergoing ambulatory knee arthroscopy in terms of efficacy and side effects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Knee Arthroscopy Spinal Anesthesia

Interventions

Isobaric 2-chloroprocaineDRUG

intrathecal injection of 50 mg isobaric 2-Chloroprocaine

Hyperbaric prilocaineDRUG

intrathecal injection of 50 mg hyperbaric prilocaine 2%

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * American Society of Anesthesiology physical status (ASA) ≤ III * Age 18-80 year * Height between 160 and 185 cm * Signed informed consent obtained prior to any study specific assessments and procedures Exclusion Criteria: * Cardiac pathology (such as Heart failure, Aortic stenosis) * Coagulation disorders (INR\>1.3, platelet \< 80 000/mm3) * Known allergy to local anaesthetics * Disagreement of the patient

Locations (2)

Braine-l'Alleud Hospital

Braine-l'Alleud, Belgium

CHU Saint-Pierre

Brussels Capital Region, Belgium

Outcomes

Primary Outcomes

Duration of sensory block

Total duration of sensory block is the interval time between the end of intrathecal injection and the complete recovery of sensory block

Time frame: Until complete release of sensory block

Secondary Outcomes

Onset time of sensory block

The levels of sensory block will be determined at 5, 10, 20 and 30 minutes after intrathecal injection. The levels of sensory block will be assessed as loss of sensation to pin-prick and cold.

Time frame: up to 30 minutes

Onset time of motor block

The levels of motor block will be determined at 5, 10, 20 and 30 minutes after intrathecal injection. The levels of motor block will be assessed by using the Bromage Scale (0=no motor block; 1=hip blocked; 2=hip and knee blocked; 3=hip, knee, and ankle blocked).

Time frame: up to 30 minutes

Duration of motor block

Total duration of motor block is the interval time between the end of intrathecal injection and the complete recovery of motor block

Time frame: Until complete regression of motor block

Pain assessed by Visual Analog Scale

Pain levels will be determined at the inflation of tourniquet, at the incision and every 10 minutes in the PACU (Post Anesthesia Care Unit). Visual Analog pain score (scale = 0 no pain; 10 = worst pain imaginable).

Time frame: up to 24 hours

Side-effects (hypotension, bradycardia, urinary retention)

Assessed during and after intervention

Time frame: up to 24 hours

Data from ClinicalTrials.gov

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