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Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00803725
First Posted: December 5, 2008
Last Update Posted: January 26, 2010
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.
Information provided by:
University Health Network, Toronto
  Purpose

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.


Condition Intervention
Knee Arthroscopy Drug: Mepivacaine without fentanyl Drug: Mepivacaine with Fentanyl

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy Surgery

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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. ]

Secondary Outcome Measures:
  • Block success, peak, and duration; time to ambulation, urination, discharge; incidence of adverse events. [ Time Frame: Up to 72 hours after surgery. ]

Estimated Enrollment: 34
Study Start Date: August 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Mepivicaine for spinal anesthesia
Drug: Mepivacaine without fentanyl
45 mg 1.5% mepivacaine injection for spinal anesthesia
Experimental: 2
Mepivacaine with Fentanyl for spinal anesthesia
Drug: Mepivacaine with Fentanyl
10 micrograms fentanyl with 30 mg 1.5% mepivacaine injection for spinal anesthesia

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803725


Locations
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Richard Brull, University Health Network
ClinicalTrials.gov Identifier: NCT00803725     History of Changes
Other Study ID Numbers: 07-0683-A
First Submitted: December 4, 2008
First Posted: December 5, 2008
Last Update Posted: January 26, 2010
Last Verified: January 2010

Keywords provided by University Health Network, Toronto:
spinal anesthesia
mepivacaine
fentanyl
duration of anesthesia
knee arthroscopy
regional anesthesia
Spinal anesthesia for knee arthroscopy

Additional relevant MeSH terms:
Anesthetics
Fentanyl
Mepivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Local