E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients scheduled for ambulatory knee arthroscopy surgery receive intrathecal chloroprocaine |
Patiënten die een knie arthroscopie ondergaan via een dag opname krijgen intrathecaal chloroprocaine |
|
E.1.1.1 | Medical condition in easily understood language |
Patients scheduled for ambulatory knee arthroscopy surgery receive intrathecal chloroprocaine |
Patiënten die een knie arthroscopie ondergaan via een dag opname krijgen intrathecaal chloroprocaine |
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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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the effective dose (ED)50 and the ED90 of Chloroprocaine for patients undergoing knee arthroscopy. |
Vaststellen van de ED50 en ED90 van chloroprocaine bij patienten die knie arthroscopie ondergaan |
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E.2.2 | Secondary objectives of the trial |
Adverse events, patiënt satisfaction |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Scheduled ambulatory knee arthroscopy
Age ≥ 18 years
ASA physical status I-II-III |
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E.4 | Principal exclusion criteria |
Allergy to chloroprocaine
Contraindication to neuraxial anaesthesia
Previous neuropathy to the lower extremities
Pregnancy
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E.5 End points |
E.5.1 | Primary end point(s) |
Successful anesthesia:
1. Complete loss of cold sensation at the L2 dermatome, AND
2. Pain is 0-2 following inflation of the tourniquet and zero upon incision
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Ice cubes are used to follow sensory block at t=2, 4, 6, 8, 10, 15, 20, 25 and 30 min, and then at 15-min intervals until the sensory blockade had regressed tot dermatome S2.
2. Pain is evaluated at inflation of the tourniquet and just before incision |
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E.5.2 | Secondary end point(s) |
1. On-set and off-set time motor block
2. Urine retention needing catheterisation
3. Transient Neurologic Syndrom (TNS)
4. Time to ambulation/hospital discharge
5. Patient satisfaction |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Motor blockade is evaluated at 5, 10, 15, 20, 25 and 30 min after intrathecal administration of the study drug, and then every 15 min until both legs can be fully elevated
2. a bladder scan is performed 30 minutes after surgery
3+5. At day 1 and 7 postoperatively, patients are interviewed by telephone
4. Day of surgery
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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 | 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 | Yes |
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 | No |
E.8.1.1 | Randomised | No |
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 | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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
|
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |