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Spinal Anesthesia Using Lidocaine and Sufentanil and (Transient Neurological Symptoms) TNS

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Vestre Viken Ringerike Sykehus
Sponsor:
Information provided by (Responsible Party):
Britt-Marie Berling, Vestre Viken Ringerike Sykehus
ClinicalTrials.gov Identifier:
NCT01283087
First received: January 21, 2011
Last updated: December 19, 2014
Last verified: December 2014
  Purpose

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


Condition
Transient Neurological Symptoms

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Spinal Anesthesia Using Lidocaine and Sufentanil and TNS (=Transient Neurological Symptoms)

Resource links provided by NLM:


Further study details as provided by Vestre Viken Ringerike Sykehus:

Primary Outcome Measures:
  • Symptoms of transient neurological symptoms [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • adults over the age of eighteen years

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283087

Contacts
Contact: Britt-Marie Berling, MD, PhD +4732116000 britt-marie.berling@vestreviken.no

Locations
Norway
Ringerike Sykehus Recruiting
Hønefoss, Norway, No 3501
Contact: Britt-Marie Berling, MD, PhD    +4732116000    britt-marie.berling@vestreviken.no   
Vestre Viken HF Ringerike Sykehus Recruiting
Hønefoss, Norway, NO-3510
Contact: Britt-Marie Berling, MD, PhD    +4732116000    britt-marie.berling@vestreviken.no   
Principal Investigator: Britt-Marie Berling, MD, PhD         
Sponsors and Collaborators
Vestre Viken Ringerike Sykehus
Investigators
Study Chair: halfdan Aas, MD, PhD Vestre Viken HF
Study Chair: halfdan Aas, MD, PhD VestreViken HF
  More Information

No publications provided

Responsible Party: Britt-Marie Berling, MD, PhD, Vestre Viken Ringerike Sykehus
ClinicalTrials.gov Identifier: NCT01283087     History of Changes
Other Study ID Numbers: 400229
Study First Received: January 21, 2011
Last Updated: December 19, 2014
Health Authority: Norway: Directorate of Health

Keywords provided by Vestre Viken Ringerike Sykehus:
TNS
Spinal anesthesia
Lidocaine

ClinicalTrials.gov processed this record on March 03, 2015