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A Pilot Study to Evaluate the Contribution of the Saphenous Nerve in Ankle Pain of Patients With Degenerative Joint Disease of the Ankle

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Steven R. Clendenen, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01716650
First received: October 24, 2012
Last updated: January 4, 2013
Last verified: January 2013
History of Changes
  Purpose

To assess the pain scores before and after saphenous nerve block placement in patients with degenerative joint disease of the ankle


Condition
Degenerative Joint Disease of the Ankle

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study to Evaluate the Contribution of the Saphenous Nerve in Ankle Pain of Patients With Degenerative Joint Disease of the Ankle

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Ankle pain [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Patient's ankle pain will be assessed prior to and after the nerve block. The study will assess if pain score is lower after the saphenous nerve block


Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Saphenous nerve block
Data collection after saphenous nerve block placement

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with degenerative joint disease of the ankle evaluated in the orthopedic department

Criteria

Inclusion Criteria:

  • Patients evaluated with osteoarthritis who are surgical candidates for ankle fusion or total ankle replacement.

Exclusion Criteria:

  • Patients with lower extremity diabetic neuropathy
  • History of prior trauma of ankle with residual nerve injury
  • Current medication of pregabalin or gabalin
  • Allergy to lidocaine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716650

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: Steven R. Clendenen, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01716650     History of Changes
Other Study ID Numbers: 09-007710
Study First Received: October 24, 2012
Last Updated: January 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
ankle
saphenous nerve block

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013