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

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 Overview

• Status: Completed
• Conditions: Spinal Anesthesia; Knee Arthroscopy
• Intervention / Treatment: Drug: Isobaric 2-chloroprocaine; Drug: Hyperbaric prilocaine

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Braine-l'Alleud, Belgium, 1420
    • Braine-l'Alleud Hospital
  • Brussels Capital Region, Belgium, 1000
    • Chu Saint-Pierre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Isobaric 2-chloroprocaine; The 50 mg dose of isobaric 2-chloroprocaine will be administered to patients undergoing ambulatory knee arthroscopy	Drug: Isobaric 2-chloroprocaine; intrathecal injection of 50 mg isobaric 2-Chloroprocaine; Other Names: Ampres
ACTIVE_COMPARATOR: Hyperbaric prilocaine 2%; The dose of 50 mg of Hyperbaric prilocaine 2% will be administered to patients undergoing ambulatory knee arthroscopy	Drug: Hyperbaric prilocaine; intrathecal injection of 50 mg hyperbaric prilocaine 2%; Other Names: Tachipri

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Until complete release of sensory block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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	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).	up to 24 hours
Side-effects (hypotension, bradycardia, urinary retention)	Assessed during and after intervention	up to 24 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Saint Pierre
• Collaborators: Hôpital de Braine-l'Alleud
• Investigators: Study Director: Emmanuel Guntz, MD, Université Libre de Bruxelles (ULB), Braine-l'Alleud Hospital; Principal Investigator: Panayota Kapessidou, MD,PhD, University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: January 26, 2017
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (ESTIMATE): February 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 15, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: spinal anesthesia; Knee arthroscopy; Local Anaesthetic
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Prilocaine; Chloroprocaine
• Other Study ID Numbers: AK160324627AD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO