Adrenaline Reduces Ecchymoses and Hematomas and Improves Quality of Life After Classic Saphenous Vein Stripping

Study Overview
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Brief Summary
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Aim of the present study is to investigate the efficiency of adrenaline (epinephrine) used locally in reducing and avoiding post-operative formation of subcutaneous ecchymoses and hematomas, in comparison with traditional practice of hemostasis, and to assess improvement in the quality of life of subjects undergoing classic great saphenous vein stripping, who received or did not receive adrenaline as a local hemostatic.

Detailed Description
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Introduction Quality of life of subjects undergoing classic great saphenous vein stripping is analogous of the gravity of subcutaneous ecchymoses and hematomas formation, as a result of surgical interventions during open surgery, when the great saphenous vein is being removed. Adrenaline (epinephrine) is a potent vasoconstrictor, whose local hemostatic ability has already been documented and applied in many medical specialties. Aim of the present study to investigate the efficiency of adrenaline (epinephrine) used locally in reducing and avoiding post-operative formation of subcutaneous ecchymoses and hematomas, in comparison with traditional practice of hemostasis, and to assess improvement in the quality of life of subjects undergoing classic great saphenous vein stripping, who received or did not receive adrenaline as a local hemostatic. Material-Methods 40 subjects diagnosed with chronic venous insufficiency (CVI) and/or varicose veins of the lower limbs of varied clinical gravity (CEAP classification II & III), admitted in the department of Vascular Surgery for open surgical management, i.e. great saphenous vein stripping +/- removal of varicosities, will be enrolled after signing an informed consent for their participation in the study. They will be then randomized into 3 separate groups: Group A - great saphenous vein stripping with local adrenaline use for hemostasis Group B - great saphenous vein stripping with local normal saline use for hemostasis Group C - great saphenous vein stripping with traditional hemostatic practice Study subjects will be followed-up after surgery, and in each group measurement of ecchymoses (small 2-5mm2 and large >5mm2) and hematomas (medium 0,2-1cm and large >1cm) will be performed by using ImageJ software after digital high-resolution photographing on 1st, 8th and 14th post-operative days. Quality of life of subjects will be assessed pre-operatively and 1 month post-operatively, by using SF-36 and CIVIQ-2 questionnaires for QoL in CVI.

Official Title
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The Role of Adrenaline in the Reduction of Subcutaneous Ecchymoses and Hematomas and in the Improvement of the Quality of Life of Patients After Classic Great Saphenous Vein Stripping

Conditions
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Venous Insufficiency (Chronic)(Peripheral), Venous Reflux, Venous Insufficiency of Leg, Venous Stasis, Venous Disease, Subcutaneous Haematoma, Ecchymosis, Bruising

Intervention / Treatment
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* Procedure: Great saphenous vein stripping and varicectomies
* Drug: Epinephrine Topical
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 years CVI CEAP Class II or III Informed consent signed Exclusion Criteria: Age <18 or >80 years CVI CEAP Class I or IV (venous ulcers) Allergy to adrenaline history No informed consent signed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Group A - great saphenous vein stripping with local adrenaline use for hemostasis | Procedure: Great saphenous vein stripping and varicectomies<br>* Removal of the great saphenous vein (partially - from just below the knee up to the saphenofemoral junction) by two 3cm skin and subcutaneous fat incisions and the introduction of a conventional vein stripper device, under general or epidural/regional anesthesia. Removal of varicose veins of the lower limb by 0,5cm skin incisions and the use of a conventional phlebectomy stainless steel hook. Mechanical hemostasis by direct compression of the thigh for 10 minutes.<br>* Other names: Saphenectomy;Drug: Epinephrine Topical<br>* Use of epinephrine/adrenaline solution 1:1000 topically<br>* Other names: Adrenaline solution 1:1000 topical/local use;|
| Sham Comparator: Group B<br>Group B - great saphenous vein stripping with local normal saline use for hemostasis | Procedure: Great saphenous vein stripping and varicectomies<br>* Removal of the great saphenous vein (partially - from just below the knee up to the saphenofemoral junction) by two 3cm skin and subcutaneous fat incisions and the introduction of a conventional vein stripper device, under general or epidural/regional anesthesia. Removal of varicose veins of the lower limb by 0,5cm skin incisions and the use of a conventional phlebectomy stainless steel hook. Mechanical hemostasis by direct compression of the thigh for 10 minutes.<br>* Other names: Saphenectomy;Drug: normal saline<br>* Use of normal saline solution NaCl 0,9% topically<br>* Other names: NaCl 0,9% topical/local use;|
| Sham Comparator: Group C<br>Group C - great saphenous vein stripping with traditional hemostatic practice | Procedure: Great saphenous vein stripping and varicectomies<br>* Removal of the great saphenous vein (partially - from just below the knee up to the saphenofemoral junction) by two 3cm skin and subcutaneous fat incisions and the introduction of a conventional vein stripper device, under general or epidural/regional anesthesia. Removal of varicose veins of the lower limb by 0,5cm skin incisions and the use of a conventional phlebectomy stainless steel hook. Mechanical hemostasis by direct compression of the thigh for 10 minutes.<br>* Other names: Saphenectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subcutaneous ecchymoses number 1d-postop | The absolute number of subcutaneous ecchymoses on the operated limb on 1st post-operative day | 24 hours post-operatively | 
| Subcutaneous ecchymoses number 8d-post-op | The absolute number of subcutaneous ecchymoses on the operated limb on 8th post-operative day | 192 hours post-operatively | 
| Subcutaneous ecchymoses number 14d-post-op | The absolute number of subcutaneous ecchymoses on the operated limb on 14th post-operative day | 336 hours post-operatively | 
| Subcutaneous hematomas number 1d-postop | The absolute number of subcutaneous hematomas in the operated limb on 1st post-operative day | 24 hours post-operatively | 
| Subcutaneous hematomas number 8d-postop | The absolute number of subcutaneous hematomas in the operated limb on 8th post-operative day | 192 hours post-operatively | 
| Subcutaneous hematomas number 14d-postop | The absolute number of subcutaneous hematomas in the operated limb on 14th post-operative day | 336 hours post-operatively | 
| Subcutaneous ecchymoses total area 1d-postop | The total area in mm2 of subcutaneous ecchymoses in the operated limb on 1st post-operative day | 24 hours post-operatively | 
| Subcutaneous ecchymoses total area 8d-postop | The total area in mm2 of subcutaneous ecchymoses in the operated limb on 8th post-operative day | 192 hours post-operatively | 
| Subcutaneous ecchymoses total area 14d-postop | The total area in mm2 of subcutaneous ecchymoses in the operated limb on 14th post-operative day | 336 hours post-operatively | 
| Subcutaneous hematomas total area 1d-postop | The total area in mm2 of subcutaneous hematomas in the operated limb on 1st post-operative day | 24 hours post-operatively | 
| Subcutaneous hematomas total area 8d-postop | The total area in mm2 of subcutaneous hematomas in the operated limb on 8th post-operative day | 192 hours post-operatively | 
| Subcutaneous hematomas total area 14d-postop | The total area in mm2 of subcutaneous hematomas in the operated limb on 14th post-operative day | 336 hours post-operatively | 
| QoL-SF36 preop | Quality of life assessment based on the 36-Item Short Form Survey (SF-36) questionnaire preoperatively. It is an often-used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study. It taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. The eight scaled scores, which are the weighted sums of the questions in their section are directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | 24 hours pre-operatively | 
| QoL-SF36 1month-postop | Quality of life assessment based on the 36-Item Short Form Survey (SF-36) questionnaire 30 days post-operatively. It is an often-used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study. It taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. The eight scaled scores, which are the weighted sums of the questions in their section are directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | 30 days post-operatively | 
| QoL-CIVIQ2 preop | Quality of life assessment based on the ChronIc Venous Insufficiency quality of life Questionnaire version 2 (CIVIQ-2) questionnaire preoperatively. The CIVIQ was developed and validated (relevance, acceptability, reliability, construct validity, and sensitivity) by French researchers in 1996. The CIVIQ is a 20-item self-reported instrument that includes four categories of questions: physical (4 items), psychological (9 items), social (4 items), and pain (3 items). Its score ranges from 0, the worst score, to 100, the best. There are five possible answers (from 1 to 5) to describe each symptom and the sensation of discomfort. The second version, the CIVIQ-2 (where 2 denotes the second draft of the same questionnaire), provides a global score covering all aspects of the questionnaire and weighs the categories equally. | 24 hours pre-operatively | 
| QoL-CIVIQ2 1month post-op | Quality of life assessment based on the CIVIQ-2 questionnaire 1 month post-operatively. Quality of life assessment based on the ChronIc Venous Insufficiency quality of life Questionnaire version 2 (CIVIQ-2) questionnaire preoperatively. The CIVIQ was developed and validated (relevance, acceptability, reliability, construct validity, and sensitivity) by French researchers in 1996. The CIVIQ is a 20-item self-reported instrument that includes four categories of questions: physical (4 items), psychological (9 items), social (4 items), and pain (3 items). Its score ranges from 0, the worst score, to 100, the best. There are five possible answers (from 1 to 5) to describe each symptom and the sensation of discomfort. The second version, the CIVIQ-2 (where 2 denotes the second draft of the same questionnaire), provides a global score covering all aspects of the questionnaire and weighs the categories equally. | 30 days post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCT preop | Hematocrit (HCT) measured pre-operatively, in percentage (%). | 24 hours pre-operatively | 
| HCT postop | Hematocrit (HCT) measured post-operatively, in percentage (%). | 24 hours post-operatively | 
| Hgb preop | Hemoglobin (Hgb) measured pre-operatively, in mg/dL. | 24 hours pre-operatively | 
| Hgb postop | Hemoglobin (Hgb) measured post-operatively, in mg/dL. | 24 hours post-operatively | 
| WBC preop | White blood cells (WBC) count measured pre-operatively, in K/mcL. | 24 hours pre-operatively | 
| WBC postop | White blood cells (WBC) count measured post-operatively, in K/mcL. | 24 hours post-operatively | 
| PLT preop | Platelet count (PLT) measured pre-operatively, in K/mcL. | 24 hours pre-operatively | 
| PLT postop | Platelet count (PLT) measured post-operatively, in K/mcL. | 24 hours post-operatively | 
| FIB preop | Fibrinogen (FIB) measured pre-operatively, in mg/dL. | 24 hours pre-operatively | 
| FIB postop | Fibrinogen (FIB) measured post-operatively, in mg/dL. | 24 hours post-operatively | 
| ESR preop | Erythrocyte sedimentation rate on the 1st hour, measured pre-operatively, in millimeters (mm). | 24 hours pre-operatively | 
| ESR postop | Erythrocyte sedimentation rate on the 1st hour, measured post-operatively, in millimeters (mm). | 24 hours post-operatively | 
| CRP preop | Serum C-reactive protein (CRP) measured pre-operatively, in mg/L. | 24 hours pre-operatively | 
| CRP postop | Serum C-reactive protein (CRP) measured post-operatively, in mg/L. | 24 hours post-operatively | 
| Experienced pain preop | Pain experienced pre-operatively assessed by a numeric rating pain scale (0-10). Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. 0 indicates no pain, 5 moderate and 10 worst possible pain. | 24 hours pre-operatively | 
| Experienced pain 1d-postop | Pain experienced pre-operatively assessed by a numeric rating pain scale (0-10). Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. 0 indicates no pain, 5 moderate and 10 worst possible pain. | 24 hours post-operatively | 
| Experienced pain 8d-postop | Pain experienced pre-operatively assessed by a numeric rating pain scale (0-10). Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. 0 indicates no pain, 5 moderate and 10 worst possible pain. | 192 hours post-operatively | 
| Experienced pain 14d-postop | Pain experienced pre-operatively assessed by a numeric rating pain scale (0-10). Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older. 0 indicates no pain, 5 moderate and 10 worst possible pain. | 336 hours post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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great saphenous vein, saphenectomy, saphenous vein stripping, ecchymosis, haematoma, adrenaline, epinephrin, hemostasis, chronic venous insufficiency, venous reflux, venous disease