E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
Does a median nerve block(injection of a local anaesthetic close to the median nerve) in the carpal tunnel ( A closed space near the wrist) provide better anaesthesia for carpal tunnel release as compared to pure subcutaneous infiltration of the local anaesthetic |
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E.2.2 | Secondary objectives of the trial |
1. Is there any difference in the pain experienced during the administration of the local anaesthetic using the two techniques? 2. How long does the effect of the local anesthesia last with the two techniques? |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Adult patients undergoing bilateral carpal tunnel release operations under local anesthesia. Carpal tunnel syndrome is a disease seen in adults (usually over the age of 35) We would only include patients with bilateral disease so that we can compare the pain scores on each side |
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E.4 | Principal exclusion criteria |
1. Patients unable to consent 2. Patients with rheumatoid arthritis. This is because the operation in these patients may involve additional procedures, eg. excision of synovium. This would bias the pain scores. 3. Patients requiring any procedure in addition to the carpal tunnel release, eg: release of a trigger finger, excision of a swelling in the same hand etc. 4. Patients requiring a general anaesthetic 5. Patients with peripheral neuropathy. These patients may have an altered pain threshold and perception 6. Patients with vascular insufficiency affecting the same hand. They are likely to have more pain due to decreased blood supply to the hand. 7. Patients undergoing re-do carpal tunnel surgery. 8. Patients deemed unfit to undergo the procedure as a day case, including those with congestive cardiac failure, liver disease, impaired respiratory function, epilepsy. 9. Patients with acute porphyrias 10. Pregnant and lactating women |
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E.5 End points |
E.5.1 | Primary end point(s) |
Intra-operative pain, (assessed with a verbal pai scale) in patients undergoing carpal tunnel decompression surgery, using 2 different techniques of administration of the local anaesthetic |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
2 techniques of administration of local anaesthetic for carpal tunnel surgery |
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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 | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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Last visit by the last patient. |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | |