Selective Unilateral Spinal Anesthesia Versus Selective Sensory Spinal Anesthesia for Knee Arthroscopy Surgery

NCT ID: NCT01356797

Last Updated: 2011-09-09

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

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-09-30

Brief Summary

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Background: Selective unilateral spinal anesthesia is the gold standard spinal anesthesia technique for knee arthroscopy. Selective sensory spinal anesthesia has recently been validated for this surgery. Both selective techniques are specially indicated for ambulatory surgery because of PACU fast track, low discharge home time and high patient satisfaction. This study compares both spinal techniques for knee arthroscopy surgery.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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hyperbaric bupivacaine

Group Type ACTIVE_COMPARATOR

hyperbaric bupivacaine 0,5%

Intervention Type DRUG

SUSA with 4 mg hyperbaric bupivacaine 0.5%

hypobaric levobupivacaine with fentanyl

Group Type EXPERIMENTAL

hypobaric levobupivacaine with fentanyl

Intervention Type DRUG

SSSA with 4 mg hypobaric levobupivacaine 0,13% with 10 mcg fentanyl

Interventions

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hypobaric levobupivacaine with fentanyl

SSSA with 4 mg hypobaric levobupivacaine 0,13% with 10 mcg fentanyl

Intervention Type DRUG

hyperbaric bupivacaine 0,5%

SUSA with 4 mg hyperbaric bupivacaine 0.5%

Intervention Type DRUG

Other Intervention Names

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Chirocane Marchaine

Eligibility Criteria

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Inclusion Criteria

* adults scheduled to undergo knee arthroscopy

Exclusion Criteria

* a previous history of neurological impairment
* insulin-dependent diabetes mellitus
* intolerance to the study drug or related compounds and additives
* BMI \> 38 kg/m2
* height \<155 cm or \>180 cm
* any existing contraindications for spinal anaesthesia
* surgery in which a complete block of the lower limb
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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USP Hospital La Colina

OTHER

Sponsor Role lead

Responsible Party

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Jesus de Santiago Moragas

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jesus Santiago Moragas

Role: PRINCIPAL_INVESTIGATOR

USP La Colina

Javier Santos-Yglesias

Role: STUDY_CHAIR

Department of Anesthesiology, Hospital La colina

Locations

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Hospital La Colina

Santa Cruz de Tenerife, Santa Cruz, Spain

Site Status

Countries

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Spain

Other Identifiers

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SUAK-1

Identifier Type: -

Identifier Source: org_study_id

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