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Does Pregabalin Reduce Pain after Ankle Surgery?

IRB Number: 28086

inactive

July 06, 2011

Institutional Review Board, Hospital for Special Surgery

The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

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For further information, see Understanding Clinical Trials/Research Studies.

Principal Investigator

Co-Investigators

  • Kethy M. Jules-Elysee, MD
  • Richard L.Kahn, MD
  • Vincent R.Lasala, MD
  • David S Levine, MD
  • Spencer Liu, MD
  • Leonardo Paroli, MD, PhD
  • Matthew M.Roberts, MD
  • Edward Lin, MD
  • Barbara Wukovits, RN, BSN
  • yadeauj@hss.edu

Summary


Inclusion/Exclusion Criteria

Inclusion Criteria: 
• Patients of Dr Levine or Dr Roberts.
• Scheduled for admission after foot or ankle surgery.
• A single-injection sciatic nerve block in the popliteal fossa is judged appropriate.
• Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate is not an exclusion criterion).
• Age ≥ 18 years

Exclusion Criteria:
• Surgery that will cause pain at sites outside the distal lower extremity (e.g. iliac crest bone graft).
• Chronic pain (defined as regular use of opioid analgesics for > 3 months).
• Contraindication to performance of the PFNB.
• Contraindication to a 30 cc 0.375% bupivacaine PFNB (e.g. alleged bupivacaine sensitivity, low body weight, etc.).
• Contraindication to use of clonidine or hydromorphone (e.g. allergy).
• Preoperative current use of pregabalin or gabapentin (“Neurontin”)
• Intolerance to pregabalin or gabapentin
• Inability of the patient to describe postoperative pain (e.g. psychiatric disorder, dementia).
• Non-English speaking patients (the questionnaire is in English, and translations would have to be separately validated)

Contact Information

Jacques T. YaDeau, MD
yadeauj@hss.edu
212.606.1206