Hyperbaric Levobupivacaine for Spinal Anaesthesia

NCT ID: NCT01938755

Last Updated: 2017-04-05

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

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-01-31

Brief Summary

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Spinal anaesthesia also called spinal block or sub-arachnoid block (SAB), is a form of regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space, generally through a fine needle.

There is no generic hyperbaric form of levobupivacaine currently available so we aimed in this study that to find the appropriate concentration of the levobupivacaine which achieves unilateral spinal anesthesia. The potential benefits of this type of anesthesia are less motor blockade and urinary retention, decrease in hospital stay. Therefore, it seems to be suitable for outpatient anesthesia.

Detailed Description

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Conditions

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This Study Was Focused on Selective Spinal Anesthesia for Lower Extremity Surgery in Order to Achieve Early Mobilization and to Shorten Hospital Stay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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levobupivacaine I

group that was administered levobupivacaine plus 60mg dextrose

Group Type EXPERIMENTAL

levobupivacaine

Intervention Type DRUG

levobupivacaine plus 60 mg dextrose

levobupivacaine II

group that was administered levobupivacaine plus 80 mg dextrose

Group Type EXPERIMENTAL

levobupivacaine

Intervention Type DRUG

levobupivacaine plus 80 mg dextrose

levobupivacaine III

group that was administered levobupivacaine plus 100 mg dextrose

Group Type EXPERIMENTAL

levobupivacaine

Intervention Type DRUG

levobupivacaine plus 100 mg dextrose

Interventions

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levobupivacaine

levobupivacaine plus 60 mg dextrose

Intervention Type DRUG

levobupivacaine

levobupivacaine plus 80 mg dextrose

Intervention Type DRUG

levobupivacaine

levobupivacaine plus 100 mg dextrose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Approval to participate in the study and spinal anesthesia
* American society of anesthesia (ASA) I,II physical status
* Scheduled for lower extremity surgery

Exclusion Criteria

* Refuse to participate in the study
* American society of anesthesia (ASA)III, IV physical status
* Hypersensitivity to local anesthetics
* Emergency surgery
* Chronic pain treatment
* Peripheral neuropathy
* Severe systemic disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ordu University

OTHER

Sponsor Role lead

Responsible Party

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özgür yağan

Özgür Yağan

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Anestesia and Reanimation Dept.; Ordu University Education and Research Hospital

Ordu, Ordu, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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odu52

Identifier Type: -

Identifier Source: org_study_id

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