Hip surgery anaesthesia and perioperative analgesia MedDRA version: 18.1 Level: LLT Classification code 10036284 Term: Post-operative hip pain System Organ Class: 100000004863 MedDRA version: 18.1 Level: PT Classification code 10051060 Term: Hip surgery System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Sponsors
Thomas Fichtner Bendtsen
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A double blinded, randomized controlled trial of success for lumbar plexus block (L2-L4) of the femoral, obturator, and lateral femoral cutaneous nerves with ultrasound/MRI image fusion guided Shamrock method vs. ultrasound guided Shamrock method. Success is assessed as motor block of the femoral and obturator nerves and sensory block of the lateral femoral cutaneous nerve in healthy volunteers.;Secondary Objective: To estimate: • Time for preparation of block • Time for block procedure • Minimal electrical nerve stimulation for release of neuromuscular response • Type of neuromuscular response on electrical nervestimulation • Number of needle proceedings • Depth of block needle • Distance between injection site in skin to the sagittal midline • Discomfort during block procedure • Middlearterial bloodpressure • Perineural spread of local anaesthetics • Epidural spread of local anaesthetics • Motor block of the af femoral, obturator, superior gluteal and sciatic nerves • Sensory block of the dermatomes T8-S3 and the lateral femoral cutaneous nerve • Cost-effectiveness • Reproducibility of diffusion weighted MRI sequences for ultrasound/MRI image fusion guided Shamrock method vs ultrasound guided Shamrock method in healthy volunteers.;Primary end point(s): Block success of the clinical relevant lumbar plexus nerves that innervate the hip joint capsule estimated as significant motor block of the femoral (L2-L4, knee extension) and obturator (L2-L3, hip adduction) nerves and significant sensory block of the lateral femoral cutaneous nerve (cold or pain). Motor block is a proxy marker for sensory block.;Timepoint(s) of evaluation of this end point: Motor block is evaluated 60 minutes after completed block procedure and sensory block is evaluated 70 minutes after completed block procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time for preparation (seconds) from placement of study participant on the bed until end of pre-ultrasoundscanning • Time for block procedure (seconds) from placement of ultrasound transducer on the skin until block needle is pulled out after injection of local anesthetics • Minimal electrical nerve stimulation for release of neuromuscular response • Type of neuromuscular response on electrical nervestimulation • Number of needle proceedings (needle proceeding followed by retraction of block needle and new needle proceeding) • Depth of tip of block needle in reference to injection site in skin (cm) • Distance between injection site in skin to the sagittal midline (cm) • Discomfort during block procedure assessed as on numeric rating scale (NRS 0-10: 0 = no discomfort, 10 = worst possible discomfort) • Middlearterial bloodpressure (MAP) after block procedure in reference to pre-block • Perineural spread of local anaesthetics added contrast estimated on MRI scanning for the spinal nerves L1-S1, the femoral, obturator, lateral femoral cutaneous nerves, and the lumbosacral trunk • Epidural spread of local anaesthetics added contrast defined as confirmed circumferential spread estimated on MRI scanning and reduced or absent cold somatosensation in two consecutive dermatomes bilaterally • Motor block of the femoral, obturator, superior gluteal and sciatic nerves estimated with dynamometer and defined as decrease in muscle strength (mmHg) of knee extension, hip adduction, hip abduction, and knee flexion, respectively, in reference to pre-block test • Success of motor block of the femoral, obturator, superior gluteal and sciatic nerves estimated with dynamometer and defined as significant motor block of knee extension, hip adduction, hip abduction, and knee flexion, respectively, in reference to pre-block test • Sensory block (cold, warmth, touch, pain) of the dermatomes T8-S3 and the lateral femoral cutaneous nerve defined as reduced or absent s | — |
Countries
Denmark
Contacts
Public ContactClinical Trial Info: Shamrock UL/MR
Thomas Fichtner Bendtsen
Outcome results
None listed