Prilocaine for Spinal Anesthesia in Ambulatory Setting

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

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.

Study Overview

• Status: Completed
• Conditions: Ambulatory Surgical Procedures; Anesthesia, Spinal; Prilocaine
• Intervention / Treatment: Drug: Prilocaine Hydrochloride

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 Type: Observational
• Enrollment (Actual): 3291

Contacts and Locations

Study Locations

• Italy
  • VA
    • Varese, VA, Italy, 21100
      • Department of Day Surgery Ospedale di Circolo Varese

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Single Center Ambulatory Surgical Patients

Description

Inclusion Criteria:

• Ambulatory surgical procedures performed under spinal anesthesia with Prilocaine

Exclusion Criteria:

• General Anesthesia
• Procedures lasting longer than 2 hours

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anesthesia-related complication	urinary retention, lipotimia, postoperative nausea, arrhythmia, hypotension, transient neurological symptoms, headache	2011-2019

Collaborators and Investigators

• Sponsor: Ospedale di Circolo - Fondazione Macchi

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2011
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): November 9, 2019

Study Registration Dates

• First Submitted: November 9, 2019
• First Submitted That Met QC Criteria: November 9, 2019
• First Posted (ACTUAL): November 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 9, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Prilocaine; Spinal Anesthesia; Ambulatory Surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Prilocaine
• Other Study ID Numbers: VAR-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No