Spinal Mepivicaine With Fentanyl for Outpatient Knee Arth... | NCT00803725

Studies
Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy

NCT00803725

Sponsor

University Health Network, Toronto

Status

Completed

Last Update Posted

Jan 26, 2010Estimated

Enrollment

34Estimated

Phase

Not Applicable

Conditions

Knee Arthroscopy

Interventions

Mepivacaine without fentanyl
Mepivacaine with Fentanyl

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Dec 4, 2008

First Submission Date that Met QC Criteria

Dec 4, 2008

First Posted Date

Dec 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2010

Last Update Posted Date

Jan 26, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Mepivicaine for spinal anesthesia	Drug: Mepivacaine without fentanyl
2	Experimental	Mepivacaine with Fentanyl for spinal anesthesia	Drug: Mepivacaine with Fentanyl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mepivacaine without fentanyl	Drug	45 mg 1.5% mepivacaine injection for spinal anesthesia	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Toronto Western Hospital		Toronto	Ontario	M5T 2S8	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19856040	Derived	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.

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds