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

This study is currently recruiting participants.
Verified March 2012 by Hospital for Special Surgery, New York
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01701102
First received: January 4, 2012
Last updated: October 3, 2012
Last verified: March 2012
History of Changes

January 4, 2012
October 3, 2012
December 2011
July 2012   (final data collection date for primary outcome measure)
Time from spinal administration to ambulation in Post-Anesthesia Care Unit (PACU) [ Time Frame: Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours. ] [ Designated as safety issue: No ]
The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery
Same as current
Complete list of historical versions of study NCT01701102 on ClinicalTrials.gov Archive Site
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Study to Find Optimal Dose of Local Spinal Anesthetic (Mepivacaine) Combined With Narcotic (Fentanyl) For Knee Surgery
Optimal Dose of Spinal Mepivacaine Combined With Fentanyl For Knee Arthroscopy

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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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Arthroscopic Knee Surgery
Procedure: Mepivacaine plus fentanyl
Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
  • Active Comparator: Mepivacaine 37.5 mg
    Intervention: Procedure: Mepivacaine plus fentanyl
  • Active Comparator: Mepivacaine 30 mg plus fentanyl 10 µg
    Intervention: Procedure: Mepivacaine plus fentanyl
  • Active Comparator: Mepivacaine 27 mg plus fentanyl 10 µg
    Intervention: Procedure: Mepivacaine plus fentanyl
  • Active Comparator: Mepivacaine 24 mg plus fentanyl 10 µg
    Intervention: Procedure: Mepivacaine plus fentanyl
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact: Richard L Kahn, MD 212.606.1206 kahnr@hss.edu
United States
 
NCT01701102
11140
No
Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
Not Provided
Not Provided
Hospital for Special Surgery, New York
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP