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Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00803725
First received: December 4, 2008
Last updated: January 22, 2010
Last verified: January 2010

December 4, 2008
January 22, 2010
August 2008
May 2009   (final data collection date for primary outcome measure)
Time to complete motor block regression (0) as measured by modified Bromage scale. [ Time Frame: Every 2 minutes from administration of the spinal until complete onset. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00803725 on ClinicalTrials.gov Archive Site
Block success, peak, and duration; time to ambulation, urination, discharge; incidence of adverse events. [ Time Frame: Up to 72 hours after surgery. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy
Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy Surgery

The purpose of this study is to determine if the addition of intrathecal fentanyl to low dose mepivacaine spinal anesthesia provides adequate surgical anesthesia with shorter duration of motor blockade.

It is hypothesized that lower doses of spinal mepivacaine when combined with fentanyl will result in adequate surgical block for knee arthroscopy surgery with faster recovery and discharge compared to mepivacaine alone.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Knee Arthroscopy
  • Drug: Mepivacaine without fentanyl
    45 mg 1.5% mepivacaine injection for spinal anesthesia
  • Drug: Mepivacaine with Fentanyl
    10 micrograms fentanyl with 30 mg 1.5% mepivacaine injection for spinal anesthesia
  • Active Comparator: 1
    Mepivicaine for spinal anesthesia
    Intervention: Drug: Mepivacaine without fentanyl
  • Experimental: 2
    Mepivacaine with Fentanyl for spinal anesthesia
    Intervention: Drug: Mepivacaine with Fentanyl
O'Donnell D, Manickam B, Perlas A, Karkhanis R, Chan VW, Syed K, Brull R. Spinal mepivacaine with fentanyl for outpatient knee arthroscopy surgery: a randomized controlled trial. Can J Anaesth. 2010 Jan;57(1):32-8. Epub 2009 Oct 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients having unilateral arthroscopic surgery of the knee;
  2. ASA I-III status;
  3. Age 18-80 years;
  4. BMI< 35.

Exclusion Criteria:

  1. Patients who have previous history of hypersensitivity to local anesthetics or contraindications for spinal anesthesia (i.e. bleeding diathesis, coagulopathy);
  2. Patients with radiating low back pain and neurological deficits in lower extremities;
  3. Patients who are incapable of giving an informed consent.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00803725
07-0683-A
No
Dr. Richard Brull, University Health Network
University Health Network, Toronto
Not Provided
Not Provided
University Health Network, Toronto
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP