E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
Our recent work has proven that the Transversus Abdominis Plane (TAP) Block is a safe and an effective analgesic regime for the treatment of post laparotomy pain. However the studies to date have used a single shot technique to achieve analgesic control. We feel that increasing the length of blockade of the anterior abdominal wall blockade will increase patient analgesia and therefore comfort. In this study we would like to compare the analgesic effects of the TAP block with catheter placement against standardised morphine based analgesia for unilateral abdominal surgery. We plan to show statistical significance in the analgesia between the two approaches. |
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E.2.2 | Secondary objectives of the trial |
Poorly controlled analgesia is associated with prolongation of hospital stay, and increased morbidity. The use of nerve blocks is a well established approach to postoperative analgesia. We plan to show that patients that received the TAP plus catheter approach had lower pain scores, mobilised earlier and in more comfort, and had shorter hospital stay. In the long term this approach may be used to facilitate day case surgery for minor abdominal surgery. The use of opioids is associated with side effects such as nausea, vomiting, pruritis and sedation, we plan to show a statistically significant difference in these side effects in the two patient groups by demonstrating a significant difference in morphine requirements
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
ASA 1-3 Age 18 - 85 years of age Patients scheduled for abdominal surgery Written Informed Consent
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E.4 | Principal exclusion criteria |
Patient refusal Outside Age Range Allergy to bupivacaine, Ropivacaine morphine, paracetamol, diclofenac sodium Skin lesions/infection at site of injection Renal or other organ dysfunction Sepsis Patients with partial or complete heart block Advanced Liver disease Acidosis or reduced plasma proteins Note: The above mentioned exclusion criteria exceeds criteria mentioned in section 4.4 of the SPC
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary measures: Severity of postoperative pain (VAS scores and categorical pain scores) Total opiate usage in the first 72 hours Time to first request for morphine
Secondary measures: sedation postoperative nausea and vomiting patient satisfaction
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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 | No |
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) | Yes |
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.8.3 |
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 | 4 |
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 | 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 | 2 |
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 |