Shamrock – Ultrasound/magnetic resonance image fusion guided block of the lumbar nervous plexus

Phase 1

• Conditions: Hip surgery anaesthesia and perioperative analgesia; MedDRA version: 18.1Level: LLTClassification code 10036284Term: Post-operative hip painSystem Organ Class: 100000004863; MedDRA version: 18.1Level: PTClassification code 10051060Term: Hip surgerySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-005544-33-DK
• Lead Sponsor: Thomas Fichtner Bendtsen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-18
• Last Update Posted: 12 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age = 18 years
• Body mass index (BMI): 18.5 = BMI =30
• Written and oral consent to participate
• Normal healthy person (American Society of Anesthesiology [ASA] Classification I)
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) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

• Volunteers not abel to speak or understand Danish
• Volunteers not able to cooperate
• Allergy against the medicines used in the study
• Daily use of analgesics
• Drug abuse – according to the investigator's judgment
• Alcohol consumption greater than the recommendations of the Danish National Board of Health
• Contraindication for MRI scan (including pregnancy)
• Volunteers in whom nerve blocks are impossible due to technical reasons or infection
• Volunteers who are incompetent, eg. surrogate consent is unaccepted

Study & Design

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