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Trial record 4 of 5 for:    guntz

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

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ClinicalTrials.gov Identifier: NCT03038958
Recruitment Status : Completed
First Posted : February 1, 2017
Last Update Posted : November 18, 2019
Sponsor:
Collaborator:
Hôpital de Braine-l'Alleud
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Knee Arthroscopy Spinal Anesthesia Drug: Isobaric 2-chloroprocaine Drug: Hyperbaric prilocaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Hyperbaric Prilocaine With Chloroprocaine for Intrathecal Anaesthesia in Day Case Knee Arthroscopy
Study Start Date : April 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Tachipri




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03038958


Locations
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Belgium
Braine-l'Alleud Hospital
Braine-l'Alleud, Belgium, 1420
CHU Saint-Pierre
Brussels Capital Region, Belgium, 1000
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Hôpital de Braine-l'Alleud
Investigators
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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)
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Responsible Party: Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT03038958    
Other Study ID Numbers: AK160324627AD
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire Saint Pierre:
Local Anaesthetic
spinal anesthesia
Knee arthroscopy
Additional relevant MeSH terms:
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Prilocaine
Chloroprocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents