Anesthesia for Pain After Ankle Fracture Surgery



Status:Recruiting
Conditions:Chronic Pain, Chronic Pain, Orthopedic
Therapuetic Areas:Musculoskeletal, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 65
Updated:10/14/2018
Start Date:March 5, 2018
End Date:August 2020
Contact:Jun-Ming Zhang, MD, MSc
Email:jun-ming.zhang@uc.edu
Phone:513-558-2427

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Pilot Study: Extended Regional Anesthesia to Prevent Chronic Pain After Ankle Fracture Surgery

This pilot study will test the hypothesis that prolonged regional peripheral nerve block will
reduce development of chronic pain in patients undergoing surgery for ankle fracture compared
to standard of care. Subjects will be followed for one year.

This pilot study will test the hypothesis that prolonged regional peripheral nerve block will
reduce development of chronic pain in patients undergoing surgery for ankle fracture.
Regional nerve block using local anesthetics delivered by ambulatory pump is used in some
types of surgeries but is not routine for ankle fracture patients in our hospitals. Patients
will be randomized to standard care (single shot peripheral nerve block prior to surgery) or
experimental (the same single shot nerve block, followed by continuous popliteal nerve block
with ropivacaine starting just after surgery). The primary outcome will be scores on a
validated ankle/foot pain questionnaire that includes questions on function. Subjects will be
followed for one year. Secondary outcome will be postoperative opioid use.

Inclusion Criteria:

- Referred for surgery for open reduction and internal fixation for ankle fracture

Exclusion Criteria:

- Unable to give informed consent in English

- Unable to complete surveys in English

- Unable to understand instructions for using pump in English

- Unavailable for followup

- Polytrauma; undergoing other surgeries or having other orthopedic injuries related to
the precipitating cause of the ankle fracture

- Infection

- Peripheral vascular disease

- Diabetes

- Currently undergoing chemotherapy

- Pregnancy

- Currently lactating

- Heart disease or heart rhythm disorder or taking anti-arrhythmic drugs

- Severe renal impairment (Class 3 or worse kidney disease)

- Liver disease (cirrhosis or liver failure)

- Prior allergic reaction to any type of local anesthetic

- Taking therapeutic doses of anti-coagulants or anti-platelet therapy (prophylactic
doses started because of hospital admission are not an exclusion)

- Currently taking antidepressants or other psychiatric medications

- Single shot local nerve block prior to surgery was ineffective

- Selected for neuraxial anesthesia rather than general anesthesia for the open
reduction surgery

- Already receiving chronic analgesic therapy for a separate chronic pain condition
We found this trial at
2
sites
234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
Phone: 513-584-2126
University of Cincinnati Medical Center Opening in 1823 as the country
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West Chester, Ohio 45069
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