Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy
Information source: University Health Network, Toronto
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Knee Arthroscopy
Intervention: Mepivacaine without fentanyl (Drug); Mepivacaine with Fentanyl (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University Health Network, Toronto Overall contact:
Alex Kerr, Phone: 416 603-5800, Ext: 6237, Email: alex.kerr@uhn.on.ca
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.
Clinical Details
Official title: Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy Surgery
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Time to complete motor block regression (0) as measured by modified Bromage scale.
Secondary outcome: Block success, peak, and duration; time to ambulation, urination, discharge; incidence of adverse events.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
Alex Kerr, Phone: 416 603-5800, Ext: 6237, Email: alex.kerr@uhn.on.ca
Toronto Western Hospital, Toronto, Ontario M5T 2S8, Canada; Recruiting
Richard Brull, MD, Principal Investigator
Additional Information
Starting date: August 2008
Ending date: April 2009
Last updated: August 7, 2009
|
