Prilocaine for Spinal Anesthesia in Ambulatory Setting

• Sponsor: Ospedale di Circolo - Fondazione Macchi (Other)
• Overall Status: Completed
• CT.gov ID: NCT04161586
• Collaborator: (none)
• Enrollment: 3,291
• Location: 1
• Actual Duration (Months): 106.3
• Patients Per Site Per Month: 31

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Spinal; Prilocaine; Ambulatory Surgical Procedures	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 Design

• Study Type: Observational
• Actual Enrollment: 3291 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Prilocaine for Spinal Anesthesia in Ambulatory Setting: an Observational Retrospective Study
• Actual Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Jun 30, 2019
• Actual Study Completion Date: Nov 9, 2019

Outcome Measures

Primary Outcome Measures

1. anesthesia-related complication [2011-2019]

   urinary retention, lipotimia, postoperative nausea, arrhythmia, hypotension, transient neurological symptoms, headache

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• Ambulatory surgical procedures performed under spinal anesthesia with Prilocaine

Exclusion Criteria:

• General Anesthesia

• Procedures lasting longer than 2 hours

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Day Surgery Ospedale di Circolo Varese	Varese	VA	Italy	21100

Sponsors and Collaborators

• Ospedale di Circolo - Fondazione Macchi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andrea Luigi Ambrosoli, Anesthesia and Intensive Care Chief - Ospedale Filippo Del Ponte, Ospedale di Circolo - Fondazione Macchi
• ClinicalTrials.gov Identifier: NCT04161586
• Other Study ID Numbers: VAR-005
• First Posted: Nov 13, 2019
• Last Update Posted: Nov 13, 2019
• Last Verified: Nov 1, 2019

• 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
• Keywords provided by Andrea Luigi Ambrosoli, Anesthesia and Intensive Care Chief - Ospedale Filippo Del Ponte, Ospedale di Circolo - Fondazione Macchi: Spinal Anesthesia; Prilocaine; Ambulatory Surgery; Safety
• Additional relevant MeSH terms: Prilocaine

Study Results

No Results Posted as of Nov 13, 2019