Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy - Full Text View

Sponsored by:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00803725

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

MedlinePlus related topics: Anesthesia

Drug Information available for: Fentanyl Citrate Fentanyl Mepivacaine Mepivacaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy Surgery

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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]

Estimated Enrollment:	34
Study Start Date:	August 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Mepivicaine for spinal anesthesia	Drug: Mepivacaine without fentanyl 45 mg 1.5% mepivacaine injection for spinal anesthesia
2: Experimental Mepivacaine with Fentanyl for spinal anesthesia	Drug: Mepivacaine with Fentanyl 10 micrograms fentanyl with 30 mg 1.5% mepivacaine injection for spinal anesthesia

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803725

Contacts

Contact: Alex Kerr

416 603-5800 ext 6237

alex.kerr@uhn.on.ca

Locations

Canada, Ontario
Toronto Western Hospital	Recruiting
Toronto, Ontario, Canada, M5T 2S8
Principal Investigator: Richard Brull, MD

Sponsors and Collaborators

University Health Network, Toronto

More Information

Responsible Party:	University Health Network ( Dr. Richard Brull )
Study ID Numbers:	07-0683-A
Study First Received:	December 4, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00803725
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:

spinal anesthesia
mepivacaine
fentanyl
duration of anesthesia

knee arthroscopy
regional anesthesia
Spinal anesthesia for knee arthroscopy

Study placed in the following topic categories:

Mepivacaine
Fentanyl

Additional relevant MeSH terms:

Anesthetics, Intravenous
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Anesthetics, Local
Pharmacologic Actions
Adjuvants, Anesthesia

Anesthetics, General
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009