Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 4, 2008
CompletedFirst Posted
Study publicly available on registry
December 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedJanuary 26, 2010
January 1, 2010
9 months
December 4, 2008
January 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to complete motor block regression (0) as measured by modified Bromage scale.
Every 2 minutes from administration of the spinal until complete onset.
Secondary Outcomes (1)
Block success, peak, and duration; time to ambulation, urination, discharge; incidence of adverse events.
Up to 72 hours after surgery.
Study Arms (2)
1
ACTIVE COMPARATORMepivicaine for spinal anesthesia
2
EXPERIMENTALMepivacaine with Fentanyl for spinal anesthesia
Interventions
10 micrograms fentanyl with 30 mg 1.5% mepivacaine injection for spinal anesthesia
Eligibility Criteria
You may qualify if:
- Patients having unilateral arthroscopic surgery of the knee;
- ASA I-III status;
- Age 18-80 years;
- BMI\< 35.
You may not qualify if:
- Patients who have previous history of hypersensitivity to local anesthetics or contraindications for spinal anesthesia (i.e. bleeding diathesis, coagulopathy);
- Patients with radiating low back pain and neurological deficits in lower extremities;
- Patients who are incapable of giving an informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Related Publications (1)
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.
PMID: 19856040DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 4, 2008
First Posted
December 5, 2008
Study Start
August 1, 2008
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
January 26, 2010
Record last verified: 2010-01