NCT02038491

Brief Summary

Regional anesthesia is the cornerstone of modern postoperative analgesia, but concerns remain about possible adverse effects and complication. RICALOR Group Investigators developed a national registry to register the incidence of regional anesthesia-associated complications and to identify possible risk factors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63,692

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

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

May 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
Last Updated

January 17, 2014

Status Verified

January 1, 2014

Enrollment Period

Same day

First QC Date

January 13, 2014

Last Update Submit

January 16, 2014

Conditions

Keywords

Epidural anesthesiaSpinal anesthesianerve blockscomplications

Outcome Measures

Primary Outcomes (1)

  • number of subjects presenting complications associated with regional anesthesia techniques

    Number of subjects presenting complications associated with regional anesthesia is recorded, and when a neurologic deficit could occur, we monitor the patient for at least 6 months

    6 months

Secondary Outcomes (1)

  • statistically significant difference in cases (complication) and controls regarding factors potentially affecting complications' occurrence

    up to dismission

Study Arms (1)

regional anesthesia

patients undergoing regional anesthesia procedures

Procedure: regional anesthesia

Interventions

Spinal, epidural, combined spinal epidural, nerve blocks

regional anesthesia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients undergoing surgery with regional anesthesia during study period will be considered for complications' incidence calculation .

You may qualify if:

  • M/F
  • undergoing surgery or procedures needing regional anesthesia
  • signed informed consent for data treatment

You may not qualify if:

  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico S Matteo

Pavia, 27100, Italy

Location

Related Publications (1)

  • Bugada Dario; Allegri Massimo; RICALOR Group investigators; Zadra Nicola; Braschi Antonio ; Borghi Battista; Grossi Paolo.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Neurologic ManifestationsCardiovascular DiseasesRespiratory Insufficiency

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 16, 2014

Study Start

May 1, 2009

Primary Completion

May 1, 2009

Study Completion

March 1, 2013

Last Updated

January 17, 2014

Record last verified: 2014-01

Locations