E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
E.1.1.1 | Medical condition in easily understood language |
Postoperative pain after hip surgery |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036236 |
E.1.2 | Term | Postoperative pain relief |
E.1.2 | System Organ Class | 100000004865 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the success rate of a novel ultrasound guided nerve block technique of the lateral femoral cutaneous nerve(LFCN) in anesthetizing the proximal area of cutaneous sensory innervation of this nerve. |
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E.2.2 | Secondary objectives of the trial |
Presenting a novel nerve block technique Evaluating the area of cutaneous sensory innervation of the LFCN |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age ≥ 18 years - Written informed consent - ASA i or II -Mentally capable of cooperating during the trial. - Understanding and speaking Danish or English.
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E.4 | Principal exclusion criteria |
- Pre-existing neurological pathology involving the area of investigation - Anatomical or mental aspects that would hinder nerve blocks - Allergy to local anesthetics - Current pregnancy - Weight less than 60 kg - Request to leave the trial - Infection in the area of injection |
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E.5 End points |
E.5.1 | Primary end point(s) |
Success rate of anesthesia in the proximal area of the cutaneous sensory innervation of the LFCN after a novel LFCN-nerve block (NB) compared to placebo. The primary endpoint is measured on a straight line through the greater trochanter and the lateral patella (TMP-line) The area of cutaneous sensory innervation is defined by the proximal and lateral area anesthetized by a supra-inguinal fascia iliaca compartment block(FICB). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Mean distance from the proximal anesthetized area after NB to the proximal anesthetized area after FICB, measured on the TMP-line. - Mean distance from the proximal anesthetized area after NB to the proximal part of the greater trochanter, measured on the TMP-line. - Mean distance from the proximal anesthetized area after FICB to the proximal part of the greater trochanter, measured on the TMP-line. - Mean distance from the distal anesthetized area after NB to the joint line between femur and tibia - Mean distance from the distal anesthetized area after FICB to the joint line between femur and tibia, on the lateral side of the thigh -Succes rate of the anesthetized area of the NB to completely cover the lines for each of the incisions: Pins, dynamic hip screws, intramedullary nail (3 incisions), anterior approach, anterolateral approach, lateral approach and posterior approach. -Succes rate of the anesthetized area of the NB to partly cover the lines for each of the incisions: Pins, dynamic hip screws, intramedullary nail (3 incisions), anterior approach, anterolateral approach, lateral approach and posterior approach. -Failure rate of the anesthetized area of the NB of covering any part of the lines for each of the incisions: Pins, dynamic hip screws, intramedullary nail (3 incisions), anterior approach, anterolateral approach, lateral approach and posterior approach. - Success rate of the anesthetized after the FICB to completely cover the distal incision for intramedullary nail. - Success rate of the anesthetized area after NB to cross an anterior midline(ASIS-P-line) through the anterior superior iliac spine (ASIS) and the central patella. - Mean distance from the medial-most part of the anesthetized area after the NB to the ASIS-P-line. - Mean maximal-distance measured perpendicular from the TMP-line to the medial part of the anesthetized area after NB - Mean maximal-distance measured perpendicular from the TMP-line to the lateral part of the anesthetized area after NB - Frequency of clinically significant femoral nerve motor block after FICB - Frequency of clinically significant femoral nerve motor block after NB - Duration of cutaneous sensory anesthesia after NB - Time used to do the NB procedure - Mean number (numeric rating scale 0-10) of discomfort during the NB procedure - Frequency of 'god', 'reduced', or 'bad' ultrasonographic view during the NB procedure - Standard deviation and percentiles of double observations in defining the delimitation of the anesthetized area |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 1: 60 minutes 90 minutes
Day 2: 30 minutes 60 minutes Approximately 12 hours
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | 4 |