Peripheral Nerve Block Compared to Intra-articular Injection for Post-operative Pain Control in Total Ankle Arthroplasty: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Total narcotic use in morphine equivalents
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intra-articular injection
Intra-articular injection at the completion of TAA procedure.
干预措施: Intra-articular injection (Procedure)
Peripheral nerve block
Pre-operative peripheral nerve block.
干预措施: Peripheral nerve block (Procedure)
结局指标
主要结局
Total narcotic use in morphine equivalents
时间窗: 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
时间窗: Up to 3 months post-operatively
Measures self-reported pain between 0 (no pain) and 100 (extreme pain)
次要结局
- 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)
研究者
Nicholas Strasser
Principal Investigator
Slocum Research & Education Foundation