NCT02282280

Brief Summary

Observation of the effects of an administration of prilocaine chlorhydrate hyperbare in rachianesthesia among a general surgical population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
380

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

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

October 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

1.2 years

First QC Date

October 31, 2014

Last Update Submit

December 29, 2015

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Duration of action

    Baseline

Study Arms (1)

Study Group

All patients included in the study

Drug: Prilocaine Chlorhydrate

Interventions

Prilocaine ChlorhydrateDRUG

Use of prilocaine in spinal anesthesia

Study Group

Eligibility Criteria

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

500 consecutive patients with a spinal anesthesia with prilocaine at Clinique Saint-Luc de Bouge

You may qualify if:

  • consecutive patients with a spinal anesthesia

You may not qualify if:

  • Patient's refusal
  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Saint-Luc Bouge

Namur, Namur, 5004, Belgium

Location

Study Officials

  • Eric P Deflandre, MD, FCCP

    Astes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Eric Deflandre, MD, FCCP

Study Record Dates

First Submitted

October 31, 2014

First Posted

November 4, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations

BE(1)