Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy

Knee Arthroscopy Clinical Trial

Official title:

Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803725
• Other study ID #: 07-0683-A
• Status: Completed
• Phase: N/A
• First received: December 4, 2008
• Last updated: January 22, 2010
• Start date: August 2008
• Est. completion date: May 2009

Study information

• Verified date: January 2010
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Arthroscopy

Intervention

Drug:
• Mepivacaine without fentanyl
45 mg 1.5% mepivacaine injection for spinal anesthesia
• Mepivacaine with Fentanyl
10 micrograms fentanyl with 30 mg 1.5% mepivacaine injection for spinal anesthesia

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to complete motor block regression (0) as measured by modified Bromage scale.		Every 2 minutes from administration of the spinal until complete onset.	No
Secondary	Block success, peak, and duration; time to ambulation, urination, discharge; incidence of adverse events.		Up to 72 hours after surgery.	No