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Completed

NCT Number: NCT03038958

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

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Key information

Conditions

Knee Arthroscopy Spinal Anesthesia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Braine-l'Alleud Hospital, Braine-l'Alleud, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isobaric 2-chloroprocaine

Drug

intrathecal injection of 50 mg isobaric 2-Chloroprocaine

Other names: Ampres

Hyperbaric prilocaine

Drug

intrathecal injection of 50 mg hyperbaric prilocaine 2%

Other names: Tachipri

Primary outcomes

  1. Duration of sensory block

    Time frame: 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 outcomes

  1. Onset time of sensory block

    Time frame: 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.

  2. Onset time of motor block

    Time frame: 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).

  3. Duration of motor block

    Time frame: 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

  4. Pain assessed by Visual Analog Scale

    Time frame: 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).

  5. Side-effects (hypotension, bradycardia, urinary retention)

    Time frame: up to 24 hours

    Assessed during and after intervention

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre

Other

Collaborators

  • Hôpital de Braine-l'Alleud

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 1, 2017
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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