Prilocaine for Spinal Anesthesia in Ambulatory Setting

NCT ID: NCT04161586

Last Updated: 2019-11-13

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

Total Enrollment

3291 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2019-11-09

Brief Summary

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The purpose of this study is to retrospectively analyze data from more than 3000 procedures, to better define the safety profile of spinal prilocaine and the incidence of complications and side effects.

Detailed Description

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We designed a retrospective cohort study to analyze the safety profile and the incidence of side effects associated with prilocaine for spinal anesthesia in ambulatory settings.

Data will be obtained from an internal database where are prospectively recorded clinical data from spinal anesthesia consecutively performed with prilocaine at our institution for ambulatory surgery from 2011 to 2019. Variables recorded in the database and analyzed will include demographic data, type of surgery, presence of surgical, anesthesiological or general complications, need for unplanned admission and percentage of completed database records.

Conditions

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Anesthesia, Spinal Prilocaine Ambulatory Surgical Procedures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Prilocaine Hydrochloride

Spinal Prilocaine for Ambulatory Surgery

Intervention Type DRUG

Other Intervention Names

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Spinal Anesthesia

Eligibility Criteria

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Inclusion Criteria

* Ambulatory surgical procedures performed under spinal anesthesia with Prilocaine

Exclusion Criteria

* General Anesthesia
* Procedures lasting longer than 2 hours
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale di Circolo - Fondazione Macchi

OTHER

Sponsor Role lead

Responsible Party

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Andrea Luigi Ambrosoli

Anesthesia and Intensive Care Chief - Ospedale Filippo Del Ponte

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Day Surgery Ospedale di Circolo Varese

Varese, VA, Italy

Site Status

Countries

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Italy

Other Identifiers

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VAR-005

Identifier Type: -

Identifier Source: org_study_id

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