Effect of High-dose Target-controlled Naloxone Infusion on Pain and Hyperalgesia in Patients following Groin-Hernia-Repair.A companion study to: Pharmacokinetics of High-dose Target-controlled Naloxone Infusion. - High-dose Target-controlled Naloxone Infusion

Rigshospitalet, Copenhagen University Hospitals0 个研究点目标入组 16 人开始时间: 2015年3月6日最近更新: 2019年12月16日

适应症

试验速览

暂无简介。

•Healthy male
•Age above 18 yrs and below 65 yrs
•Signed informed consent
•Participants submitted to unilateral, primary inguinal, open groin hernia repair 6-8 weeks prior to study start.
•Surgical procedure a.m. Lichtenstein.
•Urin-sample without traces of opioids (morphine, methadon, buprenorphine, codeine, tramadol, ketobemidone, oxycodone, hydromorphone, dextromethorphan)
•Body mass index (BMI): 18 < BMI < 30 kg/m2
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 16
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Participants, who do not speak or understand Danish
•Participants, who cannot cooperate with the investigation
•Participants, who have had previous surgery in the groin region
•Participants with pain at rest > 3 (NRS)
•Activity-related pain in the surgical field > 5 (NRS)
•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 or tattoos in the assessment areas
•Nerve lesions in the assessment sites (e.g., after trauma, disc herniation, etc.)
•Use of prescription drugs one week before the trial
•Use of over-the-counter drugs 48 hours before the trial

发起方

Rigshospitalet, Copenhagen University Hospitals