Eugene, Oregon 97401


Purpose:

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.


Study summary:

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: 1. Intra-articular Injection 2. 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.


Criteria:

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


NCT ID:

NCT03674905


Primary Contact:

Principal Investigator
Nicholas L Strasser, MD
Slocum Center for Orthopedics & Sports Medicine

Erin C Owen, PhD
Phone: 541.868.3232
Email: erin.owen@slocumfoundation.org


Backup Contact:

Email: michelle.bremer@slocumfoundation.org
Michelle Bremer, BS
Phone: 5418683217


Location Contact:

Eugene, Oregon 97401
United States

Erin C Owen, PhD
Phone: 541-868-3232
Email: erin.owen@slocumfoundation.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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