Peripheral Nerve Block Compared to Intra-articular Injection for Post-operative Pain Control in Total Ankle Arthroplasty: A Randomized, Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ankle Arthritis
- Sponsor
- Slocum Research & Education Foundation
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Total narcotic use in morphine equivalents
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Nicholas Strasser
Principal Investigator
Slocum Research & Education Foundation
Eligibility 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
Outcomes
Primary Outcomes
Total narcotic use in morphine equivalents
Time Frame: Up to 3 months post-operatively
Narcotic dose and frequency captured through patient diary; used to calculate morphine equivalents.
Self-reported pain captured with a visual analog pain scale
Time Frame: Up to 3 months post-operatively
Measures self-reported pain between 0 (no pain) and 100 (extreme pain)
Secondary Outcomes
- Time to narcotic discontinuation(Up to 3 months post-operatively)
- Foot and Ankle Ability Measure (FAAM)(Up to 3 months post-operatively)
- American Orthopaedic Foot and Ankle Society (AOFAS) Ankle Hindfoot Score(Up to 3 months post-operatively)
- Veterans Rand (VR) 36 item Health Survey(Up to 3 months post-operatively)