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NCT04161586 Clinical Trial

Prilocaine for Spinal Anesthesia in Ambulatory Setting

Anesthesia, Spinal Clinical Trial

Official title:
Prilocaine for Spinal Anesthesia in Ambulatory Setting: an Observational Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04161586
Other study ID # VAR-005
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2011
Est. completion date November 9, 2019

Study information
Verified date November 2019
Source Ospedale di Circolo - Fondazione Macchi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 3291
Est. completion date November 9, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Ambulatory surgical procedures performed under spinal anesthesia with Prilocaine

Exclusion Criteria:

- General Anesthesia

- Procedures lasting longer than 2 hours

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Prilocaine Hydrochloride
Spinal Prilocaine for Ambulatory Surgery

Locations
Country Name City State
Italy Department of Day Surgery Ospedale di Circolo Varese Varese VA

Sponsors (1)
Lead Sponsor Collaborator
Ospedale di Circolo - Fondazione Macchi

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary anesthesia-related complication urinary retention, lipotimia, postoperative nausea, arrhythmia, hypotension, transient neurological symptoms, headache 2011-2019
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