The effect of high dose naloxon - an antidote of morphine - on pain sensitivity after groin hernia repair.

Phase 1

• Conditions: Groin hernia repair; MedDRA version: 18.0Level: LLTClassification code 10049475Term: Chronic painSystem Organ Class: 100000004867; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2015-000793-36-DK
• Lead Sponsor: Rigshospitalet, Copenhagen University Hospitals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-06
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

•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)
•ASA I-II
•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

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified