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

Phase 4

Completed

• Conditions: Knee Arthroscopy; Spinal Anesthesia
• Interventions: Drug: Isobaric 2-chloroprocaine; Drug: Hyperbaric prilocaine

• Registration Number: NCT03038958
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Study First Submitted: 2017-01-26
• Study First Submitted QC: 2017-01-30
• Study First Posted: 2017-02-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isobaric 2-chloroprocaine	Isobaric 2-chloroprocaine	The 50 mg dose of isobaric 2-chloroprocaine will be administered to patients undergoing ambulatory knee arthroscopy
Hyperbaric prilocaine 2%	Hyperbaric prilocaine	The dose of 50 mg of Hyperbaric prilocaine 2% will be administered to patients undergoing ambulatory knee arthroscopy

Primary Outcome Measures

Name	Time	Method
Duration of sensory block	Until complete release 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

Secondary Outcome Measures

Name	Time	Method
Onset time of sensory block	up to 30 minutes	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.
Duration of motor block	Until complete regression 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
Side-effects (hypotension, bradycardia, urinary retention)	up to 24 hours	Assessed during and after intervention
Pain assessed by Visual Analog Scale	up to 24 hours	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).
Onset time of motor block	up to 30 minutes	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).

Trial Locations

Locations (2)

CHU Saint-Pierre; 🇧🇪 Brussels Capital Region, Belgium

Braine-l'Alleud Hospital; 🇧🇪 Braine-l'Alleud, Belgium