NCT04161586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,291

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

8.5 years

First QC Date

November 9, 2019

Last Update Submit

November 9, 2019

Conditions

Anesthesia, SpinalPrilocaineAmbulatory Surgical Procedures

Keywords

Spinal AnesthesiaPrilocaineAmbulatory SurgerySafety

Outcome Measures

Primary Outcomes (1)

  • anesthesia-related complication

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

    2011-2019

Interventions

Prilocaine HydrochlorideDRUG

Spinal Prilocaine for Ambulatory Surgery

Also known as: Spinal Anesthesia

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Single Center Ambulatory Surgical Patients

You may qualify if:

  • Ambulatory surgical procedures performed under spinal anesthesia with Prilocaine

You may not qualify if:

  • General Anesthesia
  • Procedures lasting longer than 2 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Day Surgery Ospedale di Circolo Varese

Varese, VA, 21100, Italy

Location

MeSH Terms

Interventions

PrilocaineAnesthesia, Spinal

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesia and Intensive Care Chief - Ospedale Filippo Del Ponte

Study Record Dates

First Submitted

November 9, 2019

First Posted

November 13, 2019

Study Start

January 1, 2011

Primary Completion

June 30, 2019

Study Completion

November 9, 2019

Last Updated

November 13, 2019

Record last verified: 2019-11

Locations

IT(1)