NCT01283087

Brief Summary

The purpose of this study is to find out whether patients receiving spinal anesthesia containing lidocaine and sufentanil get transient neurological symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 25, 2011

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

5.3 years

First QC Date

January 21, 2011

Last Update Submit

November 23, 2017

Conditions

Transient Neurologic Symptoms

Keywords

TNSSpinal anesthesiaLidocaine

Outcome Measures

Primary Outcomes (1)

  • Symptoms of transient neurological symptoms

    5 days

Eligibility Criteria

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

Patients who are submitted for surgery at a local hospital and where spinal anesthesia is indicated.

You may qualify if:

  • adults over the age of seventeen years

You may not qualify if:

  • patient refuse spinal anesthesia
  • spinal anesthesia is contraindicated
  • pregnancy
  • patient is incapable of giving consent
  • diabetes
  • neurological disorders
  • chronic pain
  • chronic use of analgesics
  • spinal anesthesia within five days before the actual surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ringerike Sykehus

Hønefoss, No 3501, Norway

Location

Vestre Viken HF Ringerike Sykehus

Hønefoss, NO-3510, Norway

Location

Study Officials

  • halfdan Aas, MD, PhD

    Vestre Viken HF

    STUDY CHAIR

  • halfdan Aas, MD, PhD

    VestreViken HF

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 21, 2011

First Posted

January 25, 2011

Study Start

January 1, 2011

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

November 27, 2017

Record last verified: 2017-11

Locations

NO(2)