The effect of naloxon, a drug that removes the effect of morfin), on pain hypersensitivity after a inguinal herniotomy operation.

Conditions: First degree burn injury in healthy volunteers who 6-8 weeks prior have had done a Inguinal herniotomy .
MedDRA version: 16.1Level: LLTClassification code 10049475Term: Chronic painSystem Organ Class: 100000004867
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2013-004709-17-DK

Lead Sponsor: Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

•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)
•ASA I-II
•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

Exclusion Criteria

•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