Peripheral Nerve Block Compared to Intra-articular Injection for TAA Post-operative Pain

Study Overview
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Brief Summary
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Ankle arthritis is associated with debilitating pain and chronic disability. For the treatment of severe ankle arthritis, total ankle arthroplasty (TAA) is one treatment option. Postoperative pain management in joint arthroplasty is an ongoing and relevant issue. The purpose of this study is to examine if differences exist in postoperative pain control, overall patient satisfaction, and use of narcotics using an intra-articular injection in the operating room compared with a peripheral nerve block in patients undergoing TAA.

Detailed Description
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This is a two-arm, prospective, randomized, controlled clinical study. Use of intra-articular injections in TAA are not widely reported in literature; however, they are commonly used during total knee arthroplasty's (TKAs). The purpose of this study is to examine if differences exist in postoperative pain control, overall patient satisfaction, and use of narcotics using the intra-articular injection compared with a peripheral nerve block in patients undergoing TAA. Results will contribute to the literature for the best surgical practice for pain management following a TAA for ankle arthritis. Patients will be randomized to receive one of the following interventions for pain control in the operating room: Intra-articular Injection Preoperative Peripheral Nerve Block: The study aims are: Aim 1: Determine if intra-articular injection as source of pain control for TAA lowers postoperative pain as measured by self-reported narcotic use and pain vs. the peripheral nerve block. Aim 2: Evaluate differences in functional outcomes and health related quality of life between intra-articular injections and peripheral nerve block as reported by pre- and post-operative patient questionnaires Patients who consent to participate will complete study activities pre-operatively, and at 2 weeks, 6 weeks, and 3 months post-operatively.

Official Title
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Peripheral Nerve Block Compared to Intra-articular Injection for Post-operative Pain Control in Total Ankle Arthroplasty: A Randomized, Controlled Trial

Conditions
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Ankle Arthropathy, Ankle Arthritis

Intervention / Treatment
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* Procedure: Intra-articular injection
* Procedure: Peripheral nerve block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is 40 - 80 years old Patient is having a primary, unilateral TAA Patient has signed the current, Institutional Review Board approved informed consent document Exclusion Criteria: Patient has untreated endocrine disease Patient has uncontrolled diabetes; lab result of hemoglobin A1c level > 8.0 mg/dL Patient has significant heart, liver, kidney or respiratory disease Patient has peripheral vascular disease Patient has active cancer Patient has current history of narcotic use beyond that of oral medications Patient discharge status is known to be to care facility

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- |
| Other: Intra-articular injection<br>Intra-articular injection at the completion of TAA procedure. | Procedure: Intra-articular injection<br>* Intra-articular injection at the completion of TAA procedure.<br>|
| Other: Peripheral nerve block<br>Pre-operative peripheral nerve block. | Procedure: Peripheral nerve block<br>* Pre-operative peripheral nerve block.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total narcotic use in morphine equivalents | Narcotic dose and frequency captured through patient diary; used to calculate morphine equivalents. | Up to 3 months post-operatively | 
| Self-reported pain captured with a visual analog pain scale | Measures self-reported pain between 0 (no pain) and 100 (extreme pain) | Up to 3 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot and Ankle Ability Measure (FAAM) | Measures self-reported outcomes accessing physical function for individuals with foot and ankle related impairments. | Up to 3 months post-operatively | 
| American Orthopaedic Foot and Ankle Society (AOFAS) Ankle Hindfoot Score | Grades ankle, subtalar, talonavicular, and calcaneocuboid joint levels in terms of pain (40 points), function (50 points), and alignment (10 points); 100 points possible sub-scores are summed, higher indicates better outcome. | Up to 3 months post-operatively | 
| Veterans Rand (VR) 36 item Health Survey | VR-36 Consists of select items from eight concepts of health in the VR-36, measuring health-related quality of life, and differences in disease burden. | Up to 3 months post-operatively | 
| Time to narcotic discontinuation | Number of days narcotics were taken for post-operative pain control | Up to 3 months post-operatively |