E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post-operative pain following mastectomy surgery |
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E.1.1.1 | Medical condition in easily understood language |
Pain after surgery for removal of the breast for treatment of breast 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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10024758 |
E.1.2 | Term | Local anaesthesia |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
Does a continuous infusion of levobupivacaine, a local anaesthetic, through a small tube placed at the time of surgery beneath the muscle on the chest wall, reduce post-operative pain over the initial 24 hours following mastectomy surgery? |
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E.2.2 | Secondary objectives of the trial |
Does a 24 hour continuous infusion of the local anaesthetic levobupivacaine into a tissue plane beneath the chest muscle reduce the incidence of chronic pain and improve post-operative shoulder function and arm mobility following mastectomy surgery? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All women presenting for unilateral mastectomy surgery at the Royal Cornwall Hospitals NHS Trust and Royal Devon and Exeter NHS Foundation Trust: • Female • Aged 18 years and over • Scheduled for unilateral mastectomy with or without axillary involvement |
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E.4 | Principal exclusion criteria |
• Inability to give informed consent • Primary reconstructive surgery • Known allergy or sensitivity to local anaesthetic agents, morphine, paracetamol or ondansetron • Pregnancy • Daily opioid analgesic use • Inability to understand or use a PCA device • Inability to understand or complete the visual analogue assessment tools • Concurrent participation in another interventional study that might conflict with this trial |
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E.5 End points |
E.5.1 | Primary end point(s) |
The joint primary outcomes are:- i) Total morphine consumption (mg) in the first 24 hours following surgery, including all morphine given in the Recovery Unit and cumulative PCA use as recorded by the PCA device. ii) Total pain over the first 24 hours following surgery, as defined by measurement of the area-under-the-curve of each participant’s self-reported pain scores at rest, measured using a visual analogue scale (VAS). Recordings will be made prior to leaving the Recovery Unit and at four hourly intervals throughout the first 24 hours following surgery. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The time point is at 24 hours after the end of surgery. |
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E.5.2 | Secondary end point(s) |
i) Number of PCA attempts in the first 24 hours following surgery as recorded by the PCA device. ii) VAS pain scores at 14 days and six months after surgery. iii) Brief Pain Inventory self-completion questionnaire at six months. iv) Shoulder function (as measured by the Oxford Shoulder Score at 14 days and six months following surgery. The Oxford Shoulder Score is a validated questionnaire designed to determine the impact of shoulder function on activities of daily living. It is used in orthopaedic assessment of shoulder function as a marker for indication for shoulder surgery and provides a score from 0 to 48. v) Shoulder movement assessed by goniometry at 24 hours, 14 days and six months following surgery. vi)Duration of hospital stay in days as recorded in participants’ hospital notes. vii) Incidence of post-operative nausea and/or vomiting (PONV). viii)Use of supplemental analgesics in the first 24 hours after surgery, as recorded on the inpatient drug chart. ix) Use of post-operative anti-emetics in the first 24 hours following surgery. x) Incremental cost effectiveness ratio. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Time points are detailed above. They include the following times after completion of surgery: 24 hours 2 weeks 6 months |
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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 | Yes |
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
| 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 | 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 | 3 |
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 | 3 |
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 |