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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Knee Arthroscopy Spinal Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Isobaric 2-chloroprocaine

The 50 mg dose of isobaric 2-chloroprocaine will be administered to patients undergoing ambulatory knee arthroscopy

Group Type ACTIVE_COMPARATOR

Isobaric 2-chloroprocaine

Intervention Type DRUG

intrathecal injection of 50 mg isobaric 2-Chloroprocaine

Hyperbaric prilocaine 2%

The dose of 50 mg of Hyperbaric prilocaine 2% will be administered to patients undergoing ambulatory knee arthroscopy

Group Type ACTIVE_COMPARATOR

Hyperbaric prilocaine

Intervention Type DRUG

intrathecal injection of 50 mg hyperbaric prilocaine 2%

Interventions

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Isobaric 2-chloroprocaine

intrathecal injection of 50 mg isobaric 2-Chloroprocaine

Intervention Type DRUG

Hyperbaric prilocaine

intrathecal injection of 50 mg hyperbaric prilocaine 2%

Intervention Type DRUG

Other Intervention Names

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Ampres Tachipri

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No