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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03038958
Enrollment
80
Registered
2017-02-01
Start date
2016-04-30
Completion date
2016-07-31
Last updated
2019-11-18

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

Conditions

Knee Arthroscopy, Spinal Anesthesia

Keywords

Local Anaesthetic, spinal anesthesia, Knee arthroscopy

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

Interventions

intrathecal injection of 50 mg isobaric 2-Chloroprocaine

intrathecal injection of 50 mg hyperbaric prilocaine 2%

Sponsors

Hôpital de Braine-l'Alleud
CollaboratorOTHER
Centre Hospitalier Universitaire Saint Pierre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Duration of sensory blockUntil complete release of sensory blockTotal duration of sensory block is the interval time between the end of intrathecal injection and the complete recovery of sensory block

Secondary

MeasureTime frameDescription
Onset time of sensory blockup to 30 minutesThe 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.
Onset time of motor blockup to 30 minutesThe 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).
Duration of motor blockUntil complete regression of motor blockTotal duration of motor block is the interval time between the end of intrathecal injection and the complete recovery of motor block
Pain assessed by Visual Analog Scaleup to 24 hoursPain 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).
Side-effects (hypotension, bradycardia, urinary retention)up to 24 hoursAssessed during and after intervention

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026