MedDRA version: 17.1 Level: LLT Classification code 10054710 Term: Postoperative hip pain System Organ Class: 100000004863 MedDRA version: 17.1 Level: PT Classification code 10051060 Term: Hip surgery System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Sponsors
Thomas Fichtner Bendtsen
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Male. • Age = 18 years. • Volunteers who have given their written and oral informed consent to participate in the study after fully understanding the content and the limitations of the protocol. • Normal healthy person (American Society of Anesthesiology Classification, ASA 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Volunteers not able to cooperate for the study. • Volunteers not able to understand Danish. • Daily use of analgesics. • Allergy against the medicines used in the study. • Drug abuse – according to the investigator's judgement • Alcohol consumption larger than the recommendations of the Danish National Board of Health • Volunteers in who nerve blocks are not possible due to technical reasons • Volunteers who fulfil any contraindiation for MRI including claustrophobia. • Volunteers who are incompetents, eg. surrogate consent is not accepted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to complete a double-blinded randomized controlled trial of a lumbar plexus block with the Shamrock technique versus the Lumbar Ultrasound Trident technique by estimating the time for performance of lumbar plexus block in healthy volunteers.;Secondary Objective: The secondary objective of the trial is to estimate: • Number of needle injections • Discomfort during block injection • Plasma lidocaine • Mean arterial blood pressure • Sensory block of the dermatomes T8-S3 and the terminal lumbar plexus nerves innervation • Motor block of the femoral nerve, the obturator nerve, the hip abductor muscles and the hamstring muscles • Success rate of lumbar plexus block • Distribution of local anaesthetics epidurally and surrounding the lumbar plexus nerves with MRI after lumbar plexus block • Cost-effectiveness for lumbar plexus block for the Shamrock-technique compared to the Lumbar Ultrasound Trident-technique in healthy volunteers.;Primary end point(s): Time for performance of lumbar plexus block in seconds from placement of the ultrasound transducer on the skin until the block needle is pulled out after injection of local anaesthetics.;Timepoint(s) of evaluation of this end point: When the block needle is pulled out after injection of local anaesthetics. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Number of needle feeds (retraction of needle followed by new feed of the needle disregarding of number of skin puntures). • Discomfort during block placement measured with Numeric Rating Scale (NRS 0-10) • Plasma lidocaine • Mean arterial pressure • Cost-effectiveness estimated as extra expense per successful nerve block (incremental cost-effectiveness ratio, ICER) • Sensor block (cold, warm, touch, pain) of the dermatomes T8–S3 and of the femoral nerve and the lateral femoral cutaneous nerve • Motor block of the femoral nerve (knee extension), the obturator nerve (hip adduction), the superior gluteal nerve (hip abduction) and the sciatic nerve (knee flexion) estimated as active resistance against movement of the relevant joint and with sphygmomanometer of the relevant joint as maximal voluntary isometric contraction with dynamometer (mmHg). • Success rate defined as motor block of the femoral nerve (knee extension) and the obturator nerve (hip adduction) and reduced sensory of the lateral femoral cutaneous nerve (middle of the lateral side of the thigh) • Success rate as defined above after lumbar plexus block with the Shamrock-technique for motor response on electrical nerve stimulation above respectively below 0,5 mA. • Epidural spread of local analgesics with contrast estimated with T1-, T2- and DWI-weighted MRI scanning. • Perineural spread of local analgesics with contrast estimated with T1-, T2- and DWI-weighted MRI scanning.;Timepoint(s) of evaluation of this end point: • Number of needles feeds: immediately after block placement. • Discomfort during block placement: immediately after block placement. • Plasma lidocaine: 0, 5, 10, 20, 40, 60 and 90 minutes after block placement. • Mean arterial pressure: 5 minutes after block placement. • Cost-effectiveness: after the trial is finished. • Sensor block: 30 minutes after block placement. • Motor block: 40 minutes after block placement. • Success rate: 30 minutes after block placem | — |
Countries
Denmark
Contacts
Public ContactClinical Trial Info – Shamrock
Thomas Fichtner Bendtsen
Outcome results
None listed