Effect of High-dose Naloxone Infusion on Pain and Hyperalgesia in Inguinal Post-herniotomy Patients – A Randomized, Placebo-controlled, Double-blind Study

Rigshospitalet0 个研究点开始时间: 2014年2月10日最近更新: 2014年6月2日

适应症

试验速览

暂无简介。

•Healthy male
•Age ? 18 år og ? 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 (morphin, methadon, buprenorphine, codeine, tramadol, ketobemidone, oxycodone, hydromorphone, dextromethorphan)
•Body mass index (BMI): 18 < BMI < 30
•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 14
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•Volunteers , who do not speak or understand Danish
•Volunteers, who cannot cooperate with the investigation
•Volunteers, who have had previous surgery in the groin region
•Volunteers 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 and tattoos in the assessment areas
•Nerve lesions in the assessment sites (for instance, 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