E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Comparison of Transversus Abdominis Plane (TAP) block, Ilioinguinal Nerve Block and Surgical Infiltration for Orchidoplexy and Hydrocele Repair in Children. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054711 |
E.1.2 | Term | Postoperative pain |
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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 the study is to compare the analgesic efficacy of the Transversus Abdominis Plane block, (TAP) with ilioinguinal/iliohyogastric block and wound infiltration for this surgical incision. Does the administration of levobupivacaine, into the transversus abdominis neurofascial plane (i.e. a Transversus Abdominis Plane Block, TAP Block) provide superior pain relief and reduced rescue analgesia, i.e. morphine, in children undergoing the suprapubic incision for urology surgery.
Primary Measures: Severity of Postoperative Pain via CHEOPS score Total opiate usage in the first 24 hours after surgery
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E.2.2 | Secondary objectives of the trial |
To determine the potential for the TAP Block to reduce postoperative side effects of morphine such as nausea and vomiting, and sedation in children undergoing urological surgery with a suprapubic incision.
Secondary Measures: Sedation Postoperative Nausea and Vomiting Patient (and Parent) Satisfaction
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria: Children aged 6 months to 6 years Presenting for elective or emergent urology surgery Written Informed Parental/Guardian consent ASA Grade 1 to 3
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E.4 | Principal exclusion criteria |
Exclusion Criteria: Parental/Guardian refusal Outside Age Range Allergy to Levobupivacaine, Morphine, Paracetamol, Sodium Diclofenac Skin lesions/infection at site of injection Renal or other organ dysfunction Sepsis Epilepsy/Seizure disorder
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E.5 End points |
E.5.1 | Primary end point(s) |
Severity of Postoperative Pain via CHEOPS score Total opiate usage in the first 24 hours after 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 | 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 | Yes |
E.8.1.4 | Double blind | No |
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) | Yes |
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 | Information not present in EudraCT |
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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |