The Short and Long Term Effects of Perioperative Pregabalin Use on Functional Rehabilitation, Pain Outcomes and Anxiety Following Total Hip Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial.
试验速览
- 阶段
- 4 期
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Physical function 6 weeks and 3-months post-total hip arthroplasty
研究概览
简要总结
Pain prior to surgery is of particular concern in patients undergoing total hip arthroplasty (THA) since it is the most important predictor of pain and poor function 2-3 years after surgery. Previous studies have investigated various treatments for managing pain during and after surgery. However, no study has investigated the short and long term effects of pregabalin in terms of functional rehabilitation, pain outcome and anxiety following total hip arthroplasty. Therefore, the aim of the present study is determine if the following: (1) if perioperative pregabalin administration positively influence early rehabilitation and recovery of physical function and to determine if these effects maintained at 6 weeks and 3 months post surgery. (2) To determine if perioperative pregabalin administration reduce postoperative movement evoked pain associated with rehabilitation and if these effects also maintained at 6 weeks and 3 months post surgery.
详细描述
INTRODUCTION. Participants are being asked to consider taking part in this research study if they are scheduled for total hip surgery. In this study we will compare the effect of a pain medication known as Pregabalin compared to placebo on rehabilitation and recovery of physical function and pain associated with rehabilitation. We will monitor patient progress in hospital and follow-up participants at 6 weeks and 3 months post surgery.
At the Holland Orthopedic and Arthritic Centre we use different methods to control postoperative pain. Postoperative pain relief is usually controlled with morphine using a pump that participants can control themselves, sometimes called "PCA" (Patient Controlled Analgesia). Participants also receive a combination of tablets like an anti-inflammatory (Celecoxib), and opioids (strong pain killers), to get the best pain relief possible with the fewest side effects. Anti-Inflammatories are a type of pain medicine that reduces swelling (inflammation). We would like to see compare the recovery profile of participants who receive in their pain management plan, the addition of Pregabalin with those who receive placebo.
WHY IS THIS STUDY BEING DONE? Pregabalin has recently been shown to reduce the amount of morphine participants use after surgery and enhance rehabilitation in some orthopedic participants. This study will examine whether Pregabalin added to a patient's pain management plan will help them rehabilitate more effectively and with less pain.
Part of this research will involve the collection of information from study participants that describes any pain or discomfort that they experience before and after surgery. After surgery, participants will be asked about how much pain they have by the nursing staff. In order to address these issues, they are asked to provide the following information at various intervals during their hospital stay:
- Pain intensity - using a Numeric Rating Scale (NRS) where 0=no pain and 10=Terrible Pain will be recorded three times daily during your hospital stay. Participants will also be asked to rate their pain after several rehabilitation measures on Postoperative days 1 to 4.
- Participants will also be asked if they are feeling nauseated, feel like vomiting, or feel drowsy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent, American Society of Anesthesiologists physical status I-III, VAS > 5, age18-75 years, male or female, scheduled for THA.
排除标准
- •Patients will not be enrolled in this study for the following reasons:
- •Patients not providing informed consent.
- •Known allergy to any of the medications being used.
- •History of drug or alcohol abuse.
- •Patients with chronic pain on slow-release preparations of opioid.
- •Patients with Rheumatoid Arthritis.
- •Patients with psychiatric disorders.
- •Patients unable or unwilling to use Patient Controlled Analgesia. (PCA)
- •Diabetic patients or those with impaired renal function (Creatinine >106).
- •Obese patients (i.e. BMI > 40).
研究组 & 干预措施
1
Pregabalin Group
干预措施: Pregabalin (Drug)
2
Placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
Physical function 6 weeks and 3-months post-total hip arthroplasty
时间窗: Up to 3 months
次要结局
未报告次要终点