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Completed

NCT Number: NCT04758728

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Great saphenous vein stripping and varicectomies

Procedure

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.

Other names: Saphenectomy

Epinephrine Topical

Drug

Use of epinephrine/adrenaline solution 1:1000 topically

Other names: Adrenaline solution 1:1000 topical/local use

normal saline

Drug

Use of normal saline solution NaCl 0,9% topically

Other names: NaCl 0,9% topical/local use

Primary outcomes

  1. Subcutaneous ecchymoses number 1d-postop

    Time frame: 24 hours post-operatively

    The absolute number of subcutaneous ecchymoses on the operated limb on 1st post-operative day

  2. Subcutaneous ecchymoses number 8d-post-op

    Time frame: 192 hours post-operatively

    The absolute number of subcutaneous ecchymoses on the operated limb on 8th post-operative day

  3. Subcutaneous ecchymoses number 14d-post-op

    Time frame: 336 hours post-operatively

    The absolute number of subcutaneous ecchymoses on the operated limb on 14th post-operative day

  4. Subcutaneous hematomas number 1d-postop

    Time frame: 24 hours post-operatively

    The absolute number of subcutaneous hematomas in the operated limb on 1st post-operative day

  5. Subcutaneous hematomas number 8d-postop

    Time frame: 192 hours post-operatively

    The absolute number of subcutaneous hematomas in the operated limb on 8th post-operative day

  6. Subcutaneous hematomas number 14d-postop

    Time frame: 336 hours post-operatively

    The absolute number of subcutaneous hematomas in the operated limb on 14th post-operative day

  7. Subcutaneous ecchymoses total area 1d-postop

    Time frame: 24 hours post-operatively

    The total area in mm2 of subcutaneous ecchymoses in the operated limb on 1st post-operative day

  8. Subcutaneous ecchymoses total area 8d-postop

    Time frame: 192 hours post-operatively

    The total area in mm2 of subcutaneous ecchymoses in the operated limb on 8th post-operative day

  9. Subcutaneous ecchymoses total area 14d-postop

    Time frame: 336 hours post-operatively

    The total area in mm2 of subcutaneous ecchymoses in the operated limb on 14th post-operative day

  10. Subcutaneous hematomas total area 1d-postop

    Time frame: 24 hours post-operatively

    The total area in mm2 of subcutaneous hematomas in the operated limb on 1st post-operative day

  11. Subcutaneous hematomas total area 8d-postop

    Time frame: 192 hours post-operatively

    The total area in mm2 of subcutaneous hematomas in the operated limb on 8th post-operative day

  12. Subcutaneous hematomas total area 14d-postop

    Time frame: 336 hours post-operatively

    The total area in mm2 of subcutaneous hematomas in the operated limb on 14th post-operative day

  13. QoL-SF36 preop

    Time frame: 24 hours pre-operatively

    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.

  14. QoL-SF36 1month-postop

    Time frame: 30 days post-operatively

    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.

  15. QoL-CIVIQ2 preop

    Time frame: 24 hours pre-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.

  16. QoL-CIVIQ2 1month post-op

    Time frame: 30 days post-operatively

    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.

Secondary outcomes

  1. HCT preop

    Time frame: 24 hours pre-operatively

    Hematocrit (HCT) measured pre-operatively, in percentage (%).

  2. HCT postop

    Time frame: 24 hours post-operatively

    Hematocrit (HCT) measured post-operatively, in percentage (%).

  3. Hgb preop

    Time frame: 24 hours pre-operatively

    Hemoglobin (Hgb) measured pre-operatively, in mg/dL.

  4. Hgb postop

    Time frame: 24 hours post-operatively

    Hemoglobin (Hgb) measured post-operatively, in mg/dL.

  5. WBC preop

    Time frame: 24 hours pre-operatively

    White blood cells (WBC) count measured pre-operatively, in K/mcL.

  6. WBC postop

    Time frame: 24 hours post-operatively

    White blood cells (WBC) count measured post-operatively, in K/mcL.

  7. PLT preop

    Time frame: 24 hours pre-operatively

    Platelet count (PLT) measured pre-operatively, in K/mcL.

  8. PLT postop

    Time frame: 24 hours post-operatively

    Platelet count (PLT) measured post-operatively, in K/mcL.

  9. FIB preop

    Time frame: 24 hours pre-operatively

    Fibrinogen (FIB) measured pre-operatively, in mg/dL.

  10. FIB postop

    Time frame: 24 hours post-operatively

    Fibrinogen (FIB) measured post-operatively, in mg/dL.

  11. ESR preop

    Time frame: 24 hours pre-operatively

    Erythrocyte sedimentation rate on the 1st hour, measured pre-operatively, in millimeters (mm).

  12. ESR postop

    Time frame: 24 hours post-operatively

    Erythrocyte sedimentation rate on the 1st hour, measured post-operatively, in millimeters (mm).

  13. CRP preop

    Time frame: 24 hours pre-operatively

    Serum C-reactive protein (CRP) measured pre-operatively, in mg/L.

  14. CRP postop

    Time frame: 24 hours post-operatively

    Serum C-reactive protein (CRP) measured post-operatively, in mg/L.

  15. Experienced pain preop

    Time frame: 24 hours pre-operatively

    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.

  16. Experienced pain 1d-postop

    Time frame: 24 hours post-operatively

    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.

  17. Experienced pain 8d-postop

    Time frame: 192 hours post-operatively

    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.

  18. Experienced pain 14d-postop

    Time frame: 336 hours post-operatively

    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.

Sponsors and collaborators

Lead sponsor

Junior Doctors Network-Hellas

Other

Collaborators

  • General Hospital of Rhodes Andreas Papandreou
  • Hellenic Red Cross Hospital

Registry information

Official study title

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

Acronym: ARESQOLSAVES

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 17, 2021
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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