Prilocaine for Spinal Anesthesia in Ambulatory Setting | NCT04161586

Studies
Prilocaine for Spinal Anesthesia in Ambulatory Setting

NCT04161586

Sponsor

Ospedale di Circolo - Fondazione Macchi

Status

Completed

Last Update Posted

Nov 13, 2019Actual

Enrollment

3,291Actual

Phase

Not provided

Conditions

Anesthesia, Spinal
Prilocaine
Ambulatory Surgical Procedures

Interventions

Prilocaine Hydrochloride

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2011Actual

Primary Completion Date

Jun 30, 2019Actual

Completion Date

Nov 9, 2019Actual

First Submitted Date

Nov 9, 2019

First Submission Date that Met QC Criteria

Nov 9, 2019

First Posted Date

Nov 13, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2019

Last Update Posted Date

Nov 13, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrea Luigi Ambrosoli, Anesthesia and Intensive Care Chief - Ospedale Filippo Del Ponte, Ospedale di Circolo - Fondazione MacchiPrincipal Investigator

Lead Sponsor

Ospedale di Circolo - Fondazione MacchiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,291Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prilocaine Hydrochloride	Drug	Spinal Prilocaine for Ambulatory Surgery		Spinal Anesthesia

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ambulatory surgical procedures performed under spinal anesthesia with Prilocaine

Exclusion Criteria:

General Anesthesia
Procedures lasting longer than 2 hours

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Single Center Ambulatory Surgical Patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Day Surgery Ospedale di Circolo Varese		Varese	VA	21100	Italy

Intervention Browse Module

MeSH Terms

ID	Term
D011318	Prilocaine
D000775	Anesthesia, Spinal

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided