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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
  Purpose

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.


Condition Intervention
Arthroscopic Knee Surgery
 Procedure: Mepivacaine plus fentanyl

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Optimal Dose of Spinal Mepivacaine Combined With Fentanyl For Knee Arthroscopy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 80
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mepivacaine 37.5 mg Procedure: Mepivacaine plus fentanyl
Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
Active Comparator: Mepivacaine 30 mg plus fentanyl 10 µg Procedure: Mepivacaine plus fentanyl
Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
Active Comparator: Mepivacaine 27 mg plus fentanyl 10 µg Procedure: Mepivacaine plus fentanyl
Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
Active Comparator: Mepivacaine 24 mg plus fentanyl 10 µg Procedure: Mepivacaine plus fentanyl
Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701102

Contacts
Contact: Richard L Kahn, MD 212.606.1206 kahnr@hss.edu

Locations
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Richard L Kahn, MD     212-606-1206     kahnr@hss.edu    
Principal Investigator: Richard L Kahn, MD            
Sponsors and Collaborators
Hospital for Special Surgery, New York
  More Information

No publications provided

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01701102     History of Changes
Other Study ID Numbers: 11140
Study First Received: January 4, 2012
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Mepivacaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
 Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Narcotics
Analgesics
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid

ClinicalTrials.gov processed this record on June 18, 2013