E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This study will involve the administration of levobupivicaine 0.125% and 0.25%, a local anaesthetic agent licensed for this purpose into the paravertebral space and into the surgical wound, to provide postoperative analgesia for adults having a mastecomy. We aim to compare the analgesia efficacy of paravertebral blockade with surgical wound blockade for post operative pain in the first 48 hours. |
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E.1.1.1 | Medical condition in easily understood language |
Mastectomy is surgical removal of the breast, usually for cancer. |
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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 | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054711 |
E.1.2 | Term | Postoperative pain |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
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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 |
We aim to compare the analgesic efficacy of continuous paravertebral blockade and continuous wound infiltration with a control, for post operative pain in the first 48 post operative hours, following mastectomy and, in a randomised controlled single blinded clinical trial.
Primary Measures: Total opiate usage in the first 48 hours after surgery
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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 paravertebral nerve blocks, wound catheters and morphine PCA's (patient controlled analgesia) are well established approaches to post operative analgesia. We plan to show that both paravertebral and wound catheters will provide very satisfactory analgesia post operatively. Morphine is associated with sedation, nausea, vomiting and itch. We plan to show a statistically significant decrease in these side effects in the paravertebral and wound infiltration groups. We will also look at patient satisfaction |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adults (aged 18-80) presenting for elective mastectomy + axillary surgery ASA 1 to 3 Written informed consent
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E.4 | Principal exclusion criteria |
Patient refusal Local infection at site of insertion Allergy to amide local anaesthetics, fentanyl, morphine, paracetamol, volatile anaesthetics Concurrent use of MAOIs or within 2 weeks of MAOI use Sepsis Systemic anticoagulation or coagulopathy Uncontrolled hypertension Uncontrolled Diabetes Mellitus Severe liver or cardiac dysfunction Inability to comprehend pain scoring system
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E.5 End points |
E.5.1 | Primary end point(s) |
Total opiate usage in the first 48 hours after surgery |
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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) |
Severity of Postoperative Pain, [VAS and Categorical pain Scales] Sedation Postoperative nausea, vomiting and itch Patient Satisfaction
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.8.1.3 | Single blind | No |
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.8.2.4 | Number of treatment arms in the trial | 3 |
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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The trial will be ended when 45 patients have been recruited into each group. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |