Influence of Patient Sex on Pain Control and Multimodal Analgesia in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Assess influence of sex and multimodal analgesia regimens on acute postoperative pain scores at 48 hours postoperatively, in patients undergoing TKA.
研究概览
简要总结
The purpose of this study is to examine the influence of sex on postoperative pain, following total knee arthroplasty (TKA). Patients will first be stratified by sex and then be randomized into one of two multimodal analgesic regimen (MAR), which differ in presence of pregabalin. We hypothesize that that acute postoperative pain scores are different over time between males and females and between multimodal analgesic regimens following TKA. Investigators will be blinded to which multimodal group patients are in. Patients will complete surveys in the office, during their hospital stay, and at followup intervals for up to six months.
详细描述
The overall goal of this study is to better understand the influence of patient-sex on postoperative pain perception in men versus women following total knee arthroplasty (TKA) utilizing two different multimodal analgesia regimens.
Pregabalin is a neuromuscular antagonist of voltage gated calcium channels at the post-synaptic dorsal horns in the spinal cord and brain. It binds to the alpha-2-delta subunit and interrupts pain signal transmission. The use of pregabalin as part of multimodal pain control has been associated with a decrease in postoperative opioid use.
This will be a randomized, single-blinded control trial in which patients either will or will not receive pregabalin as part of their multimodal analgesia regimen following TKA. It will be performed at a single institution, with multiple tertiary academic centers.
Patients will first be grouped according to their sex, then randomized into one of two arms:
- Multimodal analgesia regimen including pregabalin;
- Multimodal analgesia regimen not including pregabalin.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Care providers, and investigators will all be blinded to patient group identity.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, age 18-80
- •Undergoing primary unilateral TKA for primary osteoarthritis
- •English speaking
- •Patients whose primary residence is in a home and not a facility or rehabilitation center.
排除标准
- •Chronic (>6 months) use of neuromodulators pregabalin or gabapentin.
- •Pregnancy or lactation
- •Prior history of adverse reactions to pregabalin
- •Coexisting chronic pain condition rated ≥50mm on 100-mm VAS requiring narcotics.
- •Coexisting condition leading to sedation or dizziness
- •Kidney disease
- •History of angioedema
- •History of depression with suicidal ideation.
- •Extensive history of opioid/ substance use and/or abuse.
- •Receiving active or maintenance treatment for cancer or solid organ and/or marrow transplant.
- •Patient staying less than one night in the hospital.
- •Patients with a history of chronic obstructive pulmonary disease (COPD) with supplementary oxygen requirements.
结局指标
主要结局
Assess influence of sex and multimodal analgesia regimens on acute postoperative pain scores at 48 hours postoperatively, in patients undergoing TKA.
时间窗: 48 hours
Pain control measured by 100mm visual analogue scale (VAS) while at rest 48 hours after the procedure.
次要结局
- Assess how sex differences and multimodal analgesia regimens influence range of motion (ROM)(26 weeks)
- Assess how sex differences and multimodal analgesia regimens influence mental health(week 26)
- Assess how sex differences and multimodal analgesia regimens influence postoperative narcotic medication use(72 hours)
- Assess how sex differences and multimodal analgesia regimens influence postoperative narcotic medication cessation(2 weeks)
- Assess how sex differences and multimodal analgesia regimens influence chronic postoperative pain(26 weeks)
- Assess how sex differences and multimodal analgesia regimens influence physical function(26 weeks)