First degree burn injury in healthy volunteers who 6-8 weeks prior have had done a Inguinal herniotomy . MedDRA version: 16.1 Level: LLT Classification code 10049475 Term: Chronic pain System Organ Class: 100000004867
Conditions
Interventions
Trade Name: Naloxone
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Naloxone
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Concentration unit: mg/ml milligram(s)/
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
Male
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A composite measure of pain (NRS 0-10) at rest + pain during transition from supine to standing position + pain during pressure (100 kPa) at injury site, assessed six to eight weeks after a unilateral, primary, inguinal, open herniotomy following administration of naloxone.;Secondary Objective: Secondary hyperalgesia/allodynia area at injury site and contralateral site Secondary hyperalgesia induced by Brief Thermal Stimulation in the thigh contralateral to the injury site Warmth detection thresholds (WDT) and Heat Pain Detection Thresholds (HPDT) at injury site and contralateral site Mechanical pain thresholds (MPT) at injury site and contralateral site Pressure pain thresholds (PPT) at injury site and contralateral site Reaction time assessment before and after infusion Hospital Anxiety and Depression Scale (HADS) before assessments are performed Pain Catastrophizing Scale (PCS) before assessments are performed Clinical Opiate Withdrawal Scale (COWS) before assessments are performe;Primary end point(s): Primary outcome is areas of secondary hyperalgesia;Timepoint(s) of evaluation of this end point: Thermal thresholds are assessed at baseline and 1,2,3 hours after the burn injurys. Mechanical thresholds are assessed at baseline and 1,2,3,165,168,168½ hrs after the burn injurys | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Thermal and mechanical thresholds and psychometrics;Timepoint(s) of evaluation of this end point: Thermal thresholds are assessed at baseline and 1,2,3 hours after the burn injurys. Mechanical thresholds are assessed at baseline and 1,2,3,165,168,168½ hrs after the burn injurys | — |
Countries
Denmark
Contacts
Public ContactKaren Lisa Hilsted
Rigshospitalet
Outcome results
None listed