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

Sponsor:	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

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

Resource links provided by NLM:

Drug Information available for: Mepivacaine Fentanyl Fentanyl Citrate Mepivacaine hydrochloride

U.S. FDA Resources

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
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

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

Locations

Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8

Sponsors and Collaborators

University Health Network, Toronto

More Information

No publications provided by University Health Network, Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2009 Oct 24.

Responsible Party:	Dr. Richard Brull, University Health Network
ClinicalTrials.gov Identifier:	NCT00803725 History of Changes
Other Study ID Numbers:	07-0683-A
Study First Received:	December 4, 2008
Last Updated:	January 22, 2010
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

Additional relevant MeSH terms:

Anesthetics
Mepivacaine
Fentanyl
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local

Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Narcotics
Analgesics
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 09, 2012