N/A
N=56
Study to Find Optimal Dose of Local Spinal Anesthetic (Mepivacaine) Combined With Narcotic (Fentanyl) For Knee Surgery
Arthroscopic Knee Surgery
Bottom Line
View on ClinicalTrials.gov: NCT01701102 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU) — 203; 195; 156; 159 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mepivacaine (24 mg) plus fentanyl (Procedure); Mepivacaine (27 mg) plus fentanyl (Procedure); Mepivacaine (30 mg) plus fentanyl (Procedure); Mepivacaine (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU) |
203; 195; 156; 159 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Subjects aged 18-60
- Patients scheduled for "simple" knee arthroscopies, including meniscectomy, debridement, and plica.
Exclusion Criteria
- Subjects aged 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
Data sourced from ClinicalTrials.gov (NCT01701102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.