Study to Find Optimal Dose of Local Spinal Anesthetic (Mepivacaine) Combined With Narcotic (Fentanyl) For Knee Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-12-31

Brief Summary

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Prolonged motor block and delayed ability to walk are limitations of spinal anesthesia in ambulatory (same-day) surgery. This can be improved by lowering the dose of local anesthetic (a medication that, when injected around nerves, blocks nerve conduction, resulting in numbness and weakness) used in the spine, but too low a dose can result in an incomplete block (inadequate anesthesia) in some patients. There is evidence that adding a low dose of fentanyl, a narcotic, to mepivacaine enhances the anesthetic effect. The purpose of this study is to determine the lowest dose of mepivacaine, a local anesthetic, when combined with fentanyl, for which spinal anesthesia is adequate for ambulatory knee arthroscopy.

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Detailed Description

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Conditions

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Arthroscopic Knee Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mepivacaine 37.5 mg

Group Type ACTIVE_COMPARATOR

Mepivacaine

Intervention Type PROCEDURE

Mepivacaine 37.5 mg

Mepivacaine 30 mg plus fentanyl 10 µg

Group Type ACTIVE_COMPARATOR

Mepivacaine (30 mg) plus fentanyl

Intervention Type PROCEDURE

Mepivacaine (30 mg) and fentanyl (10 µg)

Mepivacaine 27 mg plus fentanyl 10 µg

Group Type ACTIVE_COMPARATOR

Mepivacaine (27 mg) plus fentanyl

Intervention Type PROCEDURE

Mepivacaine (27 mg) and fentanyl (10 µg)

Mepivacaine 24 mg plus fentanyl 10 µg

Group Type ACTIVE_COMPARATOR

Mepivacaine (24 mg) plus fentanyl

Intervention Type PROCEDURE

Mepivacaine (24 mg) and fentanyl (10 µg)

Interventions

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Mepivacaine (24 mg) plus fentanyl

Mepivacaine (24 mg) and fentanyl (10 µg)

Intervention Type PROCEDURE

Mepivacaine (27 mg) plus fentanyl

Mepivacaine (27 mg) and fentanyl (10 µg)

Intervention Type PROCEDURE

Mepivacaine (30 mg) plus fentanyl

Mepivacaine (30 mg) and fentanyl (10 µg)

Intervention Type PROCEDURE

Mepivacaine

Mepivacaine 37.5 mg

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subjects aged 18-60
* Patients scheduled for "simple" knee arthroscopies, including meniscectomy, debridement, and plica.

Exclusion Criteria

* Subjects aged \<18 or \>60
* Subjects greater than 190 cm in height
* Patients scheduled for ligament reconstruction or surgery involving bone
* Daily use of narcotics for greater than one week pre-op

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes