Predicting, Understanding, and Speeding Recovery After Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Comparison of Adjusted Trajectory Model for Pain Between Gabapentin and Placebo--Intercept
研究概览
简要总结
The objective of this research study is to better understand patterns of recovery after Total Knee Arthroplasty (TKA) amd Total Hip Replacement (THA). The study will evaluate how pain, activity and cognitive (i.e., thinking style) responses determine patterns of recovery, and the study will evaluate the efficacy of gabapentin versus placebo for improving recovery after surgery.
详细描述
The investigators propose a two-site, longitudinal, double-blind, randomized clinical intervention study to examine three specific aims:
Aim 1: Characterize the dynamic pain experience, activity, and cognitive response after TKA and determine patterns of recovery in these domains
Aim 2: Test whether gabapentin alters time course of recovery after TKA or THA in a manner dependent on its interaction with pre-drug pupil diameter and preferred style in the catastrophizing-optimism dimension
Aim 3: Test whether gabapentin increases pupil diameter in patients undergoing TKA or THA who are on high dose opioids preoperatively and to examine whether opioid use moderates the associations in Aim 1
Primary Hypothesis: Novel variance beyond established associations in recovery from pain following TKA or THA surgery is accounted for by the interaction between pupil diameter and Cognitive-Affective (C-A) state, and this interaction predicts efficacy of gabapentin to speed recovery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults scheduled for elective total knee or hip replacement
- •American Society of Anesthesiologists physical status 1-3
- •Participants must be able to read and write English
排除标准
- •Inability to complete questionnaires
- •Pregnancy
- •Litigation or workers compensation related to joint surgery
- •For 250 subjects in primary analysis - taking < 100 mg morphine equivalents/day. For 50 subjects to test gabapentin's effect on pupil diameter - taking >100 mg morphine equivalents/day
- •history of Raynaud's disease of the feet
- •suffering from a psychotic disorder or a recent psychiatric hospitalization
- •history of eye surgery or topical eye medications that would render pupillometry unreliable or would directly affect pupil diameter.
- •any disorder that would affect pupil responsivity or prevent accuracy of pupillometry such as movement disorders
研究组 & 干预措施
Gabapentin
Subjects will be randomized, stratifying for norepinephrine serotonin reuptake inhibitor (NSRI) use, to equal number to receive gabapentin or placebo pills. Drug treatment will begin 2 weeks prior to surgery and continue 3 weeks afterwards. Subjects randomized to gabapentin will receive 900 mg/day for the first week, 1800 mg/day for the next 3 weeks, and 900 mg/day for the last week.
干预措施: Gabapentin (Drug)
Placebo
Subjects will be randomized, stratifying for norepinephrine serotonin reuptake inhibitor (NSRI) use, to equal number to receive gabapentin or placebo pills. Drug treatment will begin 2 weeks prior to surgery and continue 3 weeks afterwards.
干预措施: Placebo (Drug)
结局指标
主要结局
Comparison of Adjusted Trajectory Model for Pain Between Gabapentin and Placebo--Intercept
时间窗: The first day after hospital discharge up to 5 days post surgery
Daily pain intensity report for each subject was fitted using growth curve model with parameters of intercept (modeled initial pain) and slope of change in natural log of time, adjusted for prognostic predictors for gabapentin and placebo group separately. The daily pain intensity was the WORST pain (not the average pain) in the past 24 hr on a scale where 0 is no pain and 10 is worst imaginable pain. Values represent an intercept of modeled worst daily pain on the first day after hospital discharge across all participants, extracted from the mixed effect model. The intercept is a number representative of all participants in the Arm and is an estimate with confidence limits based on the model.
Comparison of Adjusted Trajectory Model for Pain Between Gabapentin and Placebo-- Slope
时间窗: Postoperative Day 1 through Postoperative Day 60
Daily pain intensity report for each subject was fitted using growth curve model with parameters of intercept (modeled initial pain) and slope of change in natural log of time, adjusted for prognostic predictors for gabapentin and placebo group separately. The daily pain intensity was the WORST pain (not the average pain) in the past 24 hr on a scale where 0 is no pain and 10 is worst imaginable pain. Slope is defined as change in pain . Values represent the slope of modeled worst daily pain (0-10 scale as described above) divided by the natural log of time (days) across all participants, extracted from the mixed effect model. The slope is a number representative of all participants in the Arm and is an estimate with confidence limits based on the model.
Effect Pupil Diameter, Catastrophizing-optimism Construct, and Gabapentin on Model Fit of the Trajectory of Change in Worst Daily Pain After Surgery
时间窗: Postoperative Day 1 through Postoperative Day 60
Daily pain intensity report for each subject was fitted using growth curve model, adjusted for pre-specified prognostic predictors . The daily pain intensity was the WORST pain (not the average pain) in the past 24 hr on a scale where 0 is no pain and 10 is worst imaginable pain. Deviance values were calculated from the model fit with just pre-specified prognostic predictors (Model 1) and the model fit with these predictors plus pupil diameter, catastrophizing-optimism construct, gabapentin treatment and their interaction. Deviance is a goodness-of-fit statistic for a statistical model; it is often used for statistical hypothesis testing. It is a generalization of the idea of using the sum of squares of residuals (SSR) in ordinary least squares to cases where model-fitting is achieved by maximum likelihood. Deviance ranges from 0 to infinity. The smaller the number the better the model fits the sample data. Model fits were compared using Chi-squared test.
次要结局
- Iowa Gambling Task(Preoperative, 2 months after surgery, 6 months after surgery)
- Tampa Scale of Kinesiophobia(Preoperative, 2 months after surgery, 6 months after surgery)
- Wisconsin Card Sort Task(Preoperative, 2 months after surgery, 6 months after surgery)