Does adding dexamethason to a local anesathetic prolong duration of nerve block?
Phase 1
- Conditions
- Healthy volunteers (intended for postoperative pain treatment in patients after knee surgery)MedDRA version: 17.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2014-004879-23-DK
- Lead Sponsor
- Bispebjerg Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
Age 18-30 years
Men
ASA 1
BMI 18-30
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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Allergy to study medication
Earlier trauma or surgery to lower limb
Diabetes Mellitus
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate whether dexamethason as an adjuvant to ropivacaine for adductor canal block increases duration of the sensory block, when controlling for a systemic effect. ;Secondary Objective: To investigate dexamethasons effect on maximum pain scores during a tonic heat stimulation test and the potential effect on rebound pain.;Primary end point(s): Difference in duration of sensory block between dexamethason and placebo assessed as cold sensation with an alcohol swab.;Timepoint(s) of evaluation of this end point: Duration is defined as time from block performance until recovery of cold sensation to an alcohol swab, assessed every hour post-block (and every half hour when pain scores during the tonic heat stimulation test is above 0, except at 2 and 3 hours post block where there will be a break and no assessments will be performed).
- Secondary Outcome Measures
Name Time Method