Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy

January 22, 2010 updated by: University Health Network, Toronto

Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Every 2 minutes from administration of the spinal until complete onset.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

December 4, 2008

First Submitted That Met QC Criteria

December 4, 2008

First Posted (Estimate)

December 5, 2008

Study Record Updates

Last Update Posted (Estimate)

January 26, 2010

Last Update Submitted That Met QC Criteria

January 22, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-0683-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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