Anesthesia for Pain After Ankle Fracture Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Pain, Ankle Fracture Surgery, Regional Anesthesia

Intervention / Treatment
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* Drug: Ropivacaine
* Procedure: Nerve block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ropivacaine<br>Single injection of ropivacaine immediately prior to surgery | Drug: Ropivacaine<br>* Single injection of ropivacaine immediately prior to surgery.<br>* Other names: Naropin;|
| Experimental: Ropivacaine plus Nerve Block<br>Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block. | Drug: Ropivacaine<br>* Single injection of ropivacaine immediately prior to surgery.<br>* Other names: Naropin;Procedure: Nerve block<br>* insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.<br>* Other names: no other name;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score at 12 Months - Experimental Group vs. Control Group | Patients will complete Self-Administered Foot and Ankle Questionnaire (SEFAS) at 12 months post surgery. 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome. | at 12 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score at 2 Weeks - Experimental Group vs. Control Group | Patients will complete Self-Administered Foot and Ankle Questionnaire at 2 weeks post surgery. For this instrument, 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome | at 2 weeks post surgery | 
| Pain Score at 3 Months - Experimental Group vs. Control Group | Patients will complete Self-Administered Foot and Ankle Questionnaire at 3 months post surgery. 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome. | at 3 months post surgery | 
| Pain Score at 6 Months - Experimental Group vs. Control Group | Patients will complete Self-Administered Foot and Ankle Questionnaire at 6 months post surgery. 0 = worst possible pain and function, 48 = no pain or dysfunction. Higher scores indicate a better outcome. | at 6 months post surgery | 
| Incidence of Chronic Ankle Pain Diagnoses - Experimental Group vs. Control Group | Incidence of chronic ankle pain diagnoses one year after surgery obtained from the medical record was originally planned but proved difficult to obtain. Here we provide the number of patients with a 12 month Self-Administered Foot and Ankle Questionnaire score lower than 40 at the 12 month time point. For this instrument, 48 = no pain or disability; 0 = maximum pain and disability. Scores of 40 below were interpreted to indicate ongoing ankle pain of significance for pain and function, for example, at least 8 of the 12 questions being scored less than the optimal value of 4. Scores from 40 to 48 were interpreted as indicating normal or near normal function of the affected ankle. | at 1 year post surgery |