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

Spinal Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03038958
• Other study ID #: AK160324627AD
• Status: Completed
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: July 2016

Study information

• Verified date: November 2019
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroscopy
• Spinal Anesthesia

Intervention

Drug:
• Isobaric 2-chloroprocaine
intrathecal injection of 50 mg isobaric 2-Chloroprocaine
• Hyperbaric prilocaine
intrathecal injection of 50 mg hyperbaric prilocaine 2%

Locations

Country	Name	City	State
Belgium	Braine-l'Alleud Hospital	Braine-l'Alleud
Belgium	CHU Saint-Pierre	Brussels Capital Region

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre	Hôpital de Braine-l'Alleud

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Side-effects (hypotension, bradycardia, urinary retention)	Assessed during and after intervention	up to 24 hours