MedDRA version: 18.0 Level: LLT Classification code 10054710 Term: Postoperative hip pain System Organ Class: 100000004863 MedDRA version: 18.0 Level: PT Classification code 10051060 Term: Hip surgery System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Sponsors
Thomas Fichnter Bendtsen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years • Volunteer who has given their written and oral informed consent to participate in the study after fullly 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 26 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 or speak Danish • Daily use of analgesics • Allergy against the medicines used in the study • Drug abuse - according ti the investigator's estimation • Alcohol consumption larger than the recommendations of the Danish National Board of Health • Contraindication for MRI scanning including pregnancy • Volunteers in who nerve blocks are not possible due to technical reasons • Volunteers who are incompetent, eg. surrogate consent is not accepted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Time (T) = 40 minutes after the nerve block.;Main Objective: The main objective of the trial is to complete a randomized, double blinded, controlled trial with a single injection block of the lower part of the lumbar plexus (L2, L3, L4) and the upper part of the sacral plexus (L4, L5, S1) with regard to proximal analgesia of the femoral nerve, the obturator nerve, the lumbosacral trunk and the S1 spinal nerve with ultrasound/MR image fusion guided Supra Sacral Parallel Shift-technique versus ultrasound guided Supra Sacral Parallel shift-technique by estimating sensory block of the terminal nerves innervation in healthy volunteers. ;Secondary Objective: The secondary objective of the trial is to estimate time for preparation of the block, time for and discomfort during the block injection, injection site and depth of block needle, mean arterial blood pressure, sensory block of the terminal nerves innervation, calculate cost-effectiveness, and examine the distribution of local anesthetics surrounding the lumbosacral nerves with MRI for ultrasound/MR image fusion guided Supra Sacral Parallel Shift-technique versus ultrasound guided Supra Sacral Parallel shift-technique in healthy volunteers.;Primary end point(s): Success rate (SR) of block of the clinical relevant lumbosacral nerves that innervate the hip joint capsule estimated as significant motor block of the obturator nerve (L2-L3, hip adduction), the femoral nerve (L3-L4, knee extension) and the lumbosacral trunk (L4-L5, hip medial rotation) at the time T = 40 minutes. A motor block is a proxy marker of a sensory block. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Plasma-lidocaine after the nerve block • Time for preparation measured in seconds from placement of the study participant on the bed until the end of the pre-ultrasoundscanning • Time for placement of the block measured in seconds from the placement of the ultrasound transducer on the skin until the block needle is pulled out after injection of local anesthetics • Injectionsite in the skin in reference to the sagittal midline • Depth of the block needle in reference to the injectionsite • Discomfort during block placement measured with Numeric rating scale (NRS) • Mean arterial pressure after the block • Cost-effectiveness estimeret estimated as extra expense per extra successful nerve block (incremental cost-effetctiveness ratio, ICER) • Sensor block (cold, warm, touch, pain) of the femoral nerve (L2, anteriorly on thigh) and of the cutane femoral lateral nerve (L2, laterally on thigh) after the block • Perineural spread of local anesthetics with contrast estimated with T1- and T2-weighted and DWI MRI scanning after the block for the spinal nerves L2-S1, the femoral nerve, the obturator nerve, the cutane femoral lateral nerve, and the lumbosacral trunk. • Epidural spread of local anesthetics with contrast estimated with T1- and T2-weighted and DWI MRI scanning after the block.;Timepoint(s) of evaluation of this end point: • Plasma-lidocaine: 0, 5, 10, 20, 40, 60 og 90 minutes after the nerve block • Time for preparation: when the block needle penetrates the skin for the first time • Time for placement of the block: when the block needle is pulled out after injection of local anesthetics • Injectionsite: immediately after the block • Depth of block needle: immediately after the block • Discomfort: immediately after the block • Mean arterial pressure: 5 minutes after the block • Cost-effectiveness: after the trial is finished • Sensor block: 30 minutes after the block • Perineural spread of local anesthetics: 60 minutes after the block • E | — |
Countries
Denmark
Contacts
Public ContactClinical Trial Information - SSPS
Thomas Fichtner Bendtsen
Outcome results
None listed