Preemptive Analgesia With OxyContin Versus Placebo Before Surgery for Long Bone Fractures
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- post operative pain scores during first 24 hours (Visual analog scale)
研究概览
简要总结
We would like to check whether pre-operative administration of an oral controlled-release opioid formulation (Oxycodone hydrochloride (OxyContin)) could result in a clear effect of preemptive analgesia.
详细描述
Preemptive analgesia is based on the concept of treating pain before inflicting the painful stimulus. One suggested mechanism is that transmission of pain signals is altered when the patient is treated before infliction of noxious stimulation. That prevents changes from happening in the nervous system, making transformation from acute to chronic pain ("central sensitization") less likely, and thus reducing post operative pain.
Clinically, good post operative pain control has been shown to be an effective method for hastening patient convalescence and discharge. It makes part of a general approach aiming to accelerate surgical recovery through earlier enteric feeding and ambulation
OxyContin tablets deliver Oxycodone at a controlled release manner, over 12 hours. After oral administration oral bioavailability is 60-87%.
A biphasic absorption pattern is observed, describing the initial (0.6 hours) and prolonged (6.9 hours) release of Oxycodone from the OxyContin tablets. Clinical analgesia is observed within 1 hour of administration.
We believe that this mode of oral drug release is more appropriate for the perioperative pain treatment of patients undergoing short to medium term operations: with timely administration, the first absorbed part of the drug reaches the plasma before infliction of the noxious stimuli, possibly counteracting primary sensitization, and the second part absorbed, acts on post operative ongoing pain, possibly counteracting more advanced stages of neuronal plasticity.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient consent.
- •Age 18 years to 60 years.
- •Isolated limb bone fracture/s.
排除标准
- •Patient refusal.
- •Age 61 years and older.
- •Known allergy to study medication.
- •Multiple bone fractures in different limbs.
- •Multiple trauma.
- •Oncological patients.
- •Respiratory depression / respiratory insufficiency / hypercarbia.
- •Acute bronchial asthma.
- •CNS depression / hallucinations.
- •Alzheimer / dementia.
- •Known convulsive disorder.
- •Prostate hypertrophy.
- •Paralytic ileus.
- •Renal dysfunction (plasma creatinine > 1.5).
- •Liver dysfunction.
- •Adrenocortical insufficiency.
- •Hypothyroidism.
- •Pancreatitis.
- •Pregnancy and lactating.
- •Drug abuse, current or in the past.
- •Alcohol abuse on admission to operating room.
研究组 & 干预措施
study group
pre operative medication with 20 mg oxycontine PO
干预措施: Oxycodone hydrochloride (Drug)
结局指标
主要结局
post operative pain scores during first 24 hours (Visual analog scale)
时间窗: 24 hours after surgery
次要结局
- Total other pain medications at first 24 hours post operative(first 24 hours after surgery)
- Time to first oral intake(first 24 hours after surgery)
- Time to first analgesic request(at PACU)
- Length of hospitalization(after surgery)
研究者
edery
Rambam Health Care Campus
Rambam Health Care Campus