E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative pain after hip surgery |
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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 | SOC |
E.1.2 | Classification code | 10022891 |
E.1.2 | Term | Investigations |
E.1.2 | System Organ Class | 10022891 - Investigations |
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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 of a nerve block of the superior cluneal nerves (SupClun) in producing cutaneous anaesthesia posterior to - and continous with - the area of anesthesia produced by the lateral femoral cutaneous nerve (LFCN) block and the Transversalis Fascia Plane (TFP) block |
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E.2.2 | Secondary objectives of the trial |
-Evaluate the characteristics of a novel nerve block technique anaesthetising the superior cluneal nerves -Evaluate the anaesthetized skin-area after nerve block of the superior cluneal nerves - Evaluate the the superior cluneal nerve block, together with the LFCN block and the TFP block in relation to the most used incisions for hip surgery |
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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 - BMI > 30 - 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 the SupClun nerve block with local anesthetic to produce a cutaneous area of anesthesia that is continous with the anesthetized cutaneous area after a TFP nerve block, compared to placebo. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
45 minutes after nerve block |
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E.5.2 | Secondary end point(s) |
-Time to complete the SupClun nerve block -Success rate of each of the incisions (cannulated screws, DHS, IM nail, anterior-, anterolateral- lateral- and posterior approach) in being completely covered by the cutaneous anesthesia after TFP nerve block with local anaesthetic - Success rate of each of the incisions in being partly covered by the cutaneous anesthesia after TFP nerve block with local anesthetic -Rate of complete failure for each of the incisions to be covered by any cutaneous anesthesia after TFP nerve block with local anesthetic -Success rate of each of the incisions in being completely covered by the cutaneous anesthesia after LFCN nerve block and TFP block with local anesthetic - Success rate of each of the incisions in being partly covered by the cutaneous anesthesia after LFCN nerve block and TFP block with local anesthetic -Rate of complete failure for each of the incisions to be covered by any cutaneous anesthesia after LFCN nerve block and TFP block with local anesthetic -Success rate of the LFCN block to produce a cutaneous area of anesthesia that is continous with the anesthetized cutaneous area after the TFP nerve block - Success rate of the SupClun nerve block with local anesthetic to produce a relevant cutaneous area of anaesthesia, compared to placebo. - Rate of good, reduced or bad ultrasonographic visualization when doing the SubClun nerve block - Success rate of the SupClun nerve block with local anesthetic to produce a cutaneous area of anesthesia that is continous with the anesthetized cutaneous area after a LFCN nerve block, compared to placebo. - Success rate of the SupClun nerve block with local anesthetic to produce a cutaneous area of anesthesia that is continous with the anesthetized cutaneous area after both the TFP- and the LFCN nerve block, compared to placebo. - Extent of the area anaesthetised by the SupClun nerve block - Succes of the anaesthetised area of the SupClub nerve block overlapping the Greater Trochanter - Success rate of each of the incisions in being completely covered by the cutaneous anesthesia after SubClun nerve block with local anaesthetic, in combination with the the LFCN- and TFP nerve block, compared to placebo - Success rate of each of the incisions in being partly covered by the cutaneous anesthesia after SubClun nerve block with local anaesthetic, in combination with the the LFCN- and TFP nerve block, compared to placebo -Rate of complete failure for each of the incisions to be covered by any cutaneous anesthesia after SupClun nerve block with local anaesthetic, in combination with LFCN- and TFP block, compared to placebo - Rate of 'adverse reactions'
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
0 minutes (time of nerve block) 15 minutes 45 minutes after nerve blocks
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 2 |