Prilocaine for Spinal Anesthesia in Ambulatory Setting

Completed

• Conditions: Prilocaine; Anesthesia, Spinal; Ambulatory Surgical Procedures

• Registration Number: NCT04161586
• Lead Sponsor: Ospedale di Circolo - Fondazione Macchi

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2019-06-30
• Status Verified: 2019-11
• Study Completion: 2019-11-09
• Study First Submitted: 2019-11-09
• Study First Submitted QC: 2019-11-09
• Last Update Submitted: 2019-11-09
• Study First Posted: 2019-11-13
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3291

Inclusion Criteria

• Ambulatory surgical procedures performed under spinal anesthesia with Prilocaine

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Exclusion Criteria

• General Anesthesia
• Procedures lasting longer than 2 hours

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
anesthesia-related complication	2011-2019	urinary retention, lipotimia, postoperative nausea, arrhythmia, hypotension, transient neurological symptoms, headache

Trial Locations

Locations (1)

Department of Day Surgery Ospedale di Circolo Varese; 🇮🇹 Varese, VA, Italy