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

Hospital for Special Surgery (HSS)

Status: Completed

Conditions: Arthroscopic Knee Surgery

Treatments: Procedure: Mepivacaine (24 mg) plus fentanyl; Procedure: Mepivacaine; Procedure: Mepivacaine (30 mg) plus fentanyl; Procedure: Mepivacaine (27 mg) plus fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT01701102

11140

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 4 patient groups

Mepivacaine 37.5 mg

Active Comparator group

Treatment:

Procedure: Mepivacaine

Mepivacaine 30 mg plus fentanyl 10 µg

Active Comparator group

Treatment:

Procedure: Mepivacaine (30 mg) plus fentanyl

Mepivacaine 27 mg plus fentanyl 10 µg

Active Comparator group

Treatment:

Procedure: Mepivacaine (27 mg) plus fentanyl

Mepivacaine 24 mg plus fentanyl 10 µg

Active Comparator group

Treatment:

Procedure: Mepivacaine (24 mg) plus fentanyl