The use of a supraclavicular nerve catheter for local anesthetic block of the shoulder- an explorative study in healthy volunteers.
Phase 1
- Conditions
- MedDRA version: 19.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2016-002835-14-DK
- Lead Sponsor
- ordsjællands Hospital Hillerød
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Healthy volunteers aged 18 or above
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 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4
Exclusion Criteria
- Congenital or acquired sensory, motor or other neurologic damage to shoulder or upper extremity.
- BMI above 30
- Allergy to ropivacain
- Pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of the trial is to place a supraclavicular catheter in 32 healthy volunteers and examine:<br>1: If the largest shoulder nerves are affected<br>2: which other nerves are affected<br>after injection with a low (5ml) or a high (20 ml) volume of ropivacain 5 mg/ml.;Secondary Objective: Not applicable;Primary end point(s): Succesfull shoulder block (yes/no) defined as sensory affection of the axillary nerve combined with motor affection of the suprascapular nerve.;Timepoint(s) of evaluation of this end point: TB: Baseline measurement after placement of nerve catheter.<br>T1: 45 minutes after injection of ropivacain.
- Secondary Outcome Measures
Name Time Method