E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers (to investigate potential quadriceps muscle weakness following administration of a Transmuscular Quadratus Lumborum block) |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068084 |
E.1.2 | Term | Anesthesia procedure |
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 |
The aim of this study is to examine whether the administration of the TQL block cause motor block of the lumbar plexus and thereby quadriceps muscle weakness. We hypothesise that the administration of a unilateral TQL block does not cause quadriceps muscle weakness compared to a placebo block. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
To investigate the serum concentration of ropivacaine in all study participants following administration of the TQL block. We will collect blood samples from all study participants 0, 15, 30, 45 and 60 minutes after administration of the TQL block to evaluate the serum concentration of ropivacaine. The description is included in the main sutdy protocol. The results will be reported in a separate peer-review article. |
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E.3 | Principal inclusion criteria |
- Age ≥ 18 years - American Associations of Anaesthesiologist (ASA) class 1-2 - Have received written and oral information and siged the consent form - Weight > 56,5 kilograms (Chosen due to maximum single dose of ropivacaine ie. 225 milligrams).
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E.4 | Principal exclusion criteria |
- Inability to speak and understand Danish - Inability to cooperate - Allergy to study drugs - Daily intake of opioids - Alcohol and/or drug overuse - Fertile female participants: No use of safe contraceptives for the last month, positive urin-HCG or breastfeeding - Previous trauma of surgery in the abdomen, hip or knee. - Any systemic muscular or neuromuscular disease |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome in this study is the change in maximum, unilateral knee extension strength (newtonmeters (Nm)) comparing active and placebo TQL block, measured as the change from baseline to one hour after block administration. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline (before block administration) and 60 minutes following block administration |
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E.5.2 | Secondary end point(s) |
- Change in time performing the single-leg 6 meter timed hop test (Minutes, standardised protocol) comparing active and placebo TQL block, measured as the change from baseline to one hour after block administration. - Change in Timed Up and Go test (minutes, standardised protocol) - Dermatomal spread of the TQL block using standardised mechanical (pinprick) and temperature (cold and warmth) discrimination (number of dermatomes). - Change in non-invasive blood pressure from baseline to T30min - Total concentration of ropivacaine at 0, 15, 30, 45 and 60 minutes following administration of the unilateral TQL block. - Number of adverse events (Using ‘Summary of Product Characteristics’ as a guideline)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Physiological tests and dermatomal spread is evaluated 60 minutes after block administration. Physiological tests are compared to baseline. Blood samples are collected 0, 15, 30, 45 and 60 minutes after block administration. Adverse events are evaluated during the entire study (approximately 4 hours per participant) |
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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 | No |
E.6.4 | Safety | Yes |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |