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Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00803725
Recruitment Status : Completed
First Posted : December 5, 2008
Last Update Posted : January 26, 2010
Sponsor:
Information provided by:
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE December 4, 2008
First Posted Date  ICMJE December 5, 2008
Last Update Posted Date January 26, 2010
Study Start Date  ICMJE August 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2008)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00803725 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2008)
Block success, peak, and duration; time to ambulation, urination, discharge; incidence of adverse events. [ Time Frame: Up to 72 hours after surgery. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy
Official Title  ICMJE Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy Surgery
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Knee Arthroscopy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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. doi: 10.1007/s12630-009-9207-6. Epub 2009 Oct 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 4, 2008)
34
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00803725
Other Study ID Numbers  ICMJE 07-0683-A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Richard Brull, University Health Network
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Health Network, Toronto
Verification Date January 2010

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