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Does Pregabalin Reduce Pain after Ankle Surgery?

IRB Number: 28086
(inactive trial)

Institutional Review Board, Hospital for Special Surgery

July 06, 2011

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an 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.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Jacques T YaDeau, MD, PhD



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


60 patients will be enrolled.  This is a randomized placebo-controlled trial.  All patients will receive our standard analgesic regimen: a sciatic nerve block in the popliteal fossa + intravenous pain medicine (patient-controlled hydromorphone) + pills for pain (“Percocet”).  Patients will randomly receive either pregabalin or placebo (for 3 days). Pregabalin is approved for chronic pain, and is commonly but not always used at HSS (and elsewhere) for acute postoperative pain.  Patients will be followed while in the hospital, and contacted by telephone after discharge.  Patients will be asked about their pain levels, and about side effects from the pain medications.  Follow-up will last one week.

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