Effect of Intrathecal Ketorolac on Mechanical Hypersensitivity After Total Hip Arthroplasty
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Area of Hypersensitivity to Mechanical Stimuli Surrounding the Wound 48 Hours After Surgery
研究概览
简要总结
Chronic pain in patients following total hip replacement seems to be a significant problem. Previous research has shown that more effective pain management in the early postoperative period may decrease the incidence of the development of chronic pain states.
This study will evaluate whether ketorolac (a non steroidal anti-inflammatory drug) given into the spinal fluid before surgery will reduce the area of sensitivity (or pain to light touch) following surgery. Patients will be monitored during their postoperative hospital stay and then contacted by telephone at 8 weeks and 6 months after surgery and questioned about any pain they are having at their surgical site. Patients that are still experiencing pain at 6 months will be asked to return to the medical center for the study staff to assess their pain or sensitivity at the surgical site.
详细描述
Surgery results in hypersensitivity to mechanical stimuli surrounding the wound and in a subset of patients, also results in chronic pain. The purpose of the study is to test whether intrathecal ketorolac, by selectively and effectively blocking cyclooxygenase in the spinal cord, will reduce hypersensitivity surrounding the surgical wound in patients with high risk for developing chronic pain after surgery. We have chosen to study patients having total hip arthroplasty (THA) because chronic pain seems to be a significant problem after surgery. We will sample cerebrospinal fluid (CSF) prior to injection of the study medication for subsequent prostaglandin E2 (PGE2) analysis in each patient. We will also assess each patient at 48 hours after their surgery for hypersensitivity at their surgical site.
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 (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I, II, III
- •> Age 18
- •Primary unilateral total hip arthroplasty under spinal anesthesia
排除标准
- •Known allergy to study medication
- •Weight > 300 pounds
- •Obstructive sleep apnea
- •Patients with severe renal (kidney) or hepatic (liver) disease, allergy to ketorolac, amino amide local anesthetic, or contraindications to spinal anesthesia
- •Patients on dialysis for kidney failure or patients that are jaundice or have a diagnosis of liver failure
- •Patients routinely taking narcotic pain medications for pain other than their primary hip pain
- •Patients that are taking Lyrica (pregabalin) or Gabapentin (neurontin) for the treatment of seizures
研究组 & 干预措施
Ketorolac
ketorolac 2 mg ketorolac tromethamine opthalmic solution
干预措施: ketorolac tromethamine opthalmic solution (Drug)
Placebo
placebo will be added to the patient's routine spinal anesthetic for surgery
干预措施: placebo (Drug)
结局指标
主要结局
Area of Hypersensitivity to Mechanical Stimuli Surrounding the Wound 48 Hours After Surgery
时间窗: 48 hours
Hyperalgesia (using a von Frey filament) and allodynia (using a cotton swab) were evaluated around the surgical site 48 hours after surgery.
次要结局
- Present Pain Intensity(6 months)
- McGill Pain Intensity(6 months)
- McGill Affective Pain(6 months)
- Neuropathic Pain Symptom Inventory(6 months)