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| Name | Class |
|---|---|
| Slocum Center for Orthopedics and Sports Medicine | OTHER |
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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.
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:
The study aims are:
Patients who consent to participate will complete study activities pre-operatively, and at 2 weeks, 6 weeks, and 3 months post-operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-articular injection | Other | Intra-articular injection at the completion of TAA procedure. |
|
| Peripheral nerve block | Other | Pre-operative peripheral nerve block. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-articular injection | Procedure | Intra-articular injection at the completion of TAA procedure. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin C Owen, PhD | Contact | 541.868.3232 | erin.owen@slocumfoundation.org | |
| Michelle Bremer, BS | Contact | 5418683217 | michelle.bremer@slocumfoundation.org |
| Name | Affiliation | Role |
|---|---|---|
| Nicholas L Strasser, MD | Slocum Center for Orthopedics and Sports Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Slocum Research & Education Foundation | Recruiting | Eugene | Oregon | 97401 | United States |
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| ID | Term |
|---|---|
| D007270 | Injections, Intra-Articular |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Peripheral nerve block | Procedure | Pre-operative peripheral nerve block. |
|
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 |