E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Each centre will include 30 full term infants, less than 1 month of age and scheduled for major abdominal or thoracic surgery. |
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E.1.1.1 | Medical condition in easily understood language |
Each centre will include 30 full term infants, less than 1 month of age and scheduled for major abdominal or thoracic 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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The aim with the present prospective, blinded and randomized multicentre study is to establish the effectiveness and safety of EDA vs. WCI after major thoracic or abdominal surgery in neonates. |
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E.2.2 | Secondary objectives of the trial |
The study endpoints are to establish the effectiveness and safety of epidural analgesia and subcutaneous wound catheter infusion for postoperative analgesia after major thoracic or abdominal surgery in neonates. Pharmacokinetic data will presented as total and free concentration of levobupivacaine at 24, 48 and 72 hours as well as AAG at zero and 72 hours. Pharmacodynamic data will be presented as scores at 24,48 and 72 hours, total opioid consumption over 72 hours, time to start of enteral feeding, time to extubation. Further, the surgical wound will be inspected daily regarding healing, infection up to day 10 after surgery and at follow up visit. Safety data will be presented as signs (or the absence of signs) of local anesthetic systemic toxicity (LAST). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria: Following Regional Ethics Committee approval each centre includes 30 newborn infants (< 1 month of age and full term) scheduled for major abdominal or thoracic surgery (ASAI and ASA II). |
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E.4 | Principal exclusion criteria |
Exclusion criteria: Absence of parental consent. Allergy to local anaestethics. Known or suspected liver-, kidney dysfunction or neurological disorder associated with peripheral nerve damage. Intraperitoneal infection/sepsis. Reoperation within 6 weeks. Infants with another severe coexisting sickness (>ASAII). Take down enterostomy. Protocol violation. Summary of Product Charectersistics (SPC) are specified in “Fass för förskrivare, Chirocaine/levobupivacaine”. (Se bilaga SPC levobupivacaine).
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E.5 End points |
E.5.1 | Primary end point(s) |
Endpoints The study endpoints are to establish the effectiveness and safety of epidural analgesia and subcutaneous wound catheter infusion for postoperative analgesia after major thoracic or abdominal surgery in neonates. Pharmacokinetic data will presented as total and free concentration of levobupivacaine at 24, 48 and 72 hours as well as AAG at zero and 72 hours. Pharmacodynamic data will be presented as scores at 24,48 and 72 hours, total opioid consumption over 72 hours, time to start of enteral feeding, time to extubation. Further, the surgical wound will be inspected daily regarding healing, infection up to day 10 after surgery and at follow up visit. Safety data will be presented as signs (or the absence of signs) of local anesthetic systemic toxicity (LAST). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Study ends at 72 hours postoperatively. |
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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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Same drug, concentration and dose/kg delivered by 2 different techniques |
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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 | Yes |
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 | |
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 | 2 |