Effect of High-dose Naloxone Infusion on Pain and Hyperalgesia in Patients Following Groin-Hernia Repair. A Randomized, Placebo-controlled, Double-blind Crossover Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Summated pain intensity
研究概览
简要总结
Recent studies have focused on the role of endogenous opioids on central sensitization. Central sensitization is known to be impaired or altered in chronic pain conditions, as fibromyalgia or chronic tension headache.
Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone administration after resolution of an injury. This suggests latent sensitization.
In the present study, investigators hypothesize that a high-dose target-controlled naloxone infusion (total dose: 3.25 mg/kg) can reinstate pain and hyperalgesia 6-8 weeks after a unilateral primary open groin hernia repair procedure. Investigators aim to show that latent sensitization is present in humans and is modulated by endogenous opioids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤ 65 years
- •Signed informed consent
- •Patients submitted to unilateral, primary inguinal, open herniotomy 6-8 weeks prior to study start.
- •Open operating procedure a.m. Lichtenstein.
- •Urin sample without traces of opioids (morphine, methadon, buprenorphine, codeine, tramadol, ketobemidone, oxycodone, hydromorphine, dextromethorphan)
- •Body mass index (BMI): 18 < BMI < 30
排除标准
- •Volunteers , who do not speak or understand Danish
- •Patients, who cannot cooperate with the investigation
- •Patients who have had previous surgery in the groin region
- •Patients with pain at rest > 3 (NRS)
- •Activity-related pain in the surgical field > 5
- •Allergic reaction against morphine or other opioids (including naloxone),
- •Abuse of alcohol or drugs - according to investigator's evaluation
- •Use of psychotropic drugs (exception of SSRI)
- •Neurologic or psychiatric disease
- •Chronic pain condition
- •Regular use of analgesic drugs
- •Skin lesions and tattoos in the assessment areas
- •Nerve lesions in the assessment sites (for instance, after trauma, disc herniation, etc.)
- •Use of prescription drugs 1 week before the trial
- •Use of over-the-counter drugs 48 hours before the trial
研究组 & 干预措施
Placebo
Change in Pain Ratings (NRS) at the surgical site and at the mirror-site in the contralateral groin six to eight weeks after unilateral herniotomy following administration of placebo.
干预措施: Placebo (Drug)
Target-controlled naloxone-infusion (total dose: 3.25 mg/kg)
Change in Pain Ratings (NRS) at the surgical site and at the mirror-site in the contralateral groin six to eight weeks after unilateral herniotomy following administration of naloxone.
干预措施: Target-controlled naloxone-infusion (Drug)
结局指标
主要结局
Summated pain intensity
时间窗: 1st session: 6-8 weeks after surgery; 2nd session: one week later
Change in pain ratings (\[NRS,0-10\] pain at rest + pain during transition from supine to standing position + pain during pressure (100 kPa) at injury site), assessed 6-8 weeks after unilateral, primary, open groin hernia repair following administration of naloxone/placebo.
次要结局
- Secondary hyperalgesia/allodynia(1st session: 6-8 weeks after surgery; 2nd session: one week later)
- Pressure pain thresholds(1st session: 6-8 weeks; 2nd session: one week later)
研究者
Mads Werner
Physician
Rigshospitalet, Denmark