E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pain of injection of a tumescent anaesthetic solution used during EndoVenous Laser Ablation of Varicose Veins. |
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E.1.1.1 | Medical condition in easily understood language |
Reducing the pain of laser treatment for varicose veins |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
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 principle research objective is to determine whether the addition of sodium bicarbonate to tumescent anaesthesia results in less pain than conventional tumescent anaesthesia alone, when used during endovenous laser ablation of the Great Saphenous Vein. |
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E.2.2 | Secondary objectives of the trial |
The secondary research objectives are to see whether this modification to the tumescent anaesthesia also has other benefits over the unbuffered solution, such as reduced requirements for pain-killers, less bruising and other complications, improved quality of life and quicker return to full activity. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients aged 18 or over • Primary symptomatic superficial venous insufficiency, CEAP grades C2-C6 • Suitable to undergo EVLA of the GSV to address SFJ and/or GSV reflux on duplex assessment o Defined as retrograde flow ≥ 1second in duration on spectral Doppler analysis • Willing and able to participate and able to give valid, informed consent |
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E.4 | Principal exclusion criteria |
• Unsuitability for EVLA due to either technical or patient-related factors • Unwillingness/ inability to comply with the requirements for follow-up visits • Known allergy or contraindication to receive any constituents of the study anaesthesia • Varicose veins not due to SFJ or truncal GSV reflux • Pregnant/lactating women • Active Deep Venous Thrombosis/post-thrombotic syndrome of treatment leg • Active or recent (within last 6 weeks) thrombophlebitis of the treatment leg • Previous ipsilateral varicose vein treatment • Patients with impalpable foot pulses and Ankle-Brachial Pressure Index (ABPI) less than 0.8 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The principal research objective is to assess whether the addition of sodium bicarbonate to standard tumescent anaesthesia results in less periprocedural pain, as reported by the patient using a 100m Visual Analogue Scale. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Upon completion of the procedure, patients will be asked to score the pain they experienced using a 100mm Visual Analogue Scale (VAS) from 0 (No pain) to 100 (Worst pain imaginable). |
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E.5.2 | Secondary end point(s) |
1. VAS pain scores and analgesia requirements for one week post-EVLA 2. Patient- and investigator-percieved bruising at one, six and twelve weeks 3. Incidence of haematoma formation - observed clinically and on Ultrasound at one, six and twelve weeks 4. Generic and Disease-specific QoL at one, six and twelve weeks 5. Time to return to work/usual activities |
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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 | 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 |
No sodium bicarbonate added to the control group tumescent anaesthesia |
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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 | 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 | 0 |
E.8.9.1 | In the Member State concerned days | 29 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |