Clinical trial NCT04758728: Adrenaline Reduces Ecchymoses and Hematomas and Improves Quality of Life After Classic Saphenous Vein Stripping
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Insufficiency (Chronic)(Peripheral)
Venous Reflux
Venous Insufficiency of Leg
Venous Stasis
Venous Disease
Subcutaneous Haematoma
Ecchymosis
Bruising
Keywords: great saphenous vein
saphenectomy
saphenous vein stripping
ecchymosis
haematoma
adrenaline
epinephrin
hemostasis
chronic venous insufficiency
venous reflux
venous disease
Lead sponsor: Junior Doctors Network-Hellas
Sponsor class: OTHER
Collaborators: name: General Hospital of Rhodes Andreas Papandreou
name: Hellenic Red Cross Hospital
First posted: 2021-02-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Subcutaneous ecchymoses number 1d-postop
timeFrame: 24 hours post-operatively
measure: Subcutaneous ecchymoses number 8d-post-op
timeFrame: 192 hours post-operatively
measure: Subcutaneous ecchymoses number 14d-post-op
timeFrame: 336 hours post-operatively
measure: Subcutaneous hematomas number 1d-postop
timeFrame: 24 hours post-operatively
measure: Subcutaneous hematomas number 8d-postop
timeFrame: 192 hours post-operatively
measure: Subcutaneous hematomas number 14d-postop
timeFrame: 336 hours post-operatively
measure: Subcutaneous ecchymoses total area 1d-postop
timeFrame: 24 hours post-operatively
measure: Subcutaneous ecchymoses total area 8d-postop
timeFrame: 192 hours post-operatively
measure: Subcutaneous ecchymoses total area 14d-postop
timeFrame: 336 hours post-operatively
measure: Subcutaneous hematomas total area 1d-postop
timeFrame: 24 hours post-operatively
measure: Subcutaneous hematomas total area 8d-postop
timeFrame: 192 hours post-operatively
measure: Subcutaneous hematomas total area 14d-postop
timeFrame: 336 hours post-operatively
measure: QoL-SF36 preop
timeFrame: 24 hours pre-operatively
measure: QoL-SF36 1month-postop
timeFrame: 30 days post-operatively
measure: QoL-CIVIQ2 preop
timeFrame: 24 hours pre-operatively
measure: QoL-CIVIQ2 1month post-op
timeFrame: 30 days post-operatively
Secondary outcomes:
measure: HCT preop
timeFrame: 24 hours pre-operatively
measure: HCT postop
timeFrame: 24 hours post-operatively
measure: Hgb preop
timeFrame: 24 hours pre-operatively
measure: Hgb postop
timeFrame: 24 hours post-operatively
measure: WBC preop
timeFrame: 24 hours pre-operatively
measure: WBC postop
timeFrame: 24 hours post-operatively
measure: PLT preop
timeFrame: 24 hours pre-operatively
measure: PLT postop
timeFrame: 24 hours post-operatively
measure: FIB preop
timeFrame: 24 hours pre-operatively
measure: FIB postop
timeFrame: 24 hours post-operatively
measure: ESR preop
timeFrame: 24 hours pre-operatively
measure: ESR postop
timeFrame: 24 hours post-operatively
measure: CRP preop
timeFrame: 24 hours pre-operatively
measure: CRP postop
timeFrame: 24 hours post-operatively
measure: Experienced pain preop
timeFrame: 24 hours pre-operatively
measure: Experienced pain 1d-postop
timeFrame: 24 hours post-operatively
measure: Experienced pain 8d-postop
timeFrame: 192 hours post-operatively
measure: Experienced pain 14d-postop
timeFrame: 336 hours post-operatively
Other outcomes:
Locations:
city: Rhodes
country: Greece
facility: Department of Vascular Surgery, Andreas Papandreou General Hospital
state: South Aegean
Study officials:
affiliation: JDN-Hellas / Department of Vascular Surgery, Hellenic Red Cross Hospital
name: Konstantinos Roditis, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Vascular Surgery, Andreas Papandreou General Hospital
name: Dimitrios Mavros, MD, MSc, PhD
role: STUDY_CHAIR
References:
citation: Furuya T, Tada Y, Sato O. A new technique for reducing subcutaneous hemorrhage after stripping of the great saphenous vein. J Vasc Surg. 1992 Sep;16(3):493-4. doi: 10.1016/0741-5214(92)90389-p. No abstract available.
citation: Nisar A, Shabbir J, Tubassam MA, Shah AR, Khawaja N, Kavanagh EG, Grace PA, Burke PE. Local anaesthetic flush reduces postoperative pain and haematoma formation after great saphenous vein stripping--a randomised controlled trial. Eur J Vasc Endovasc Surg. 2006 Mar;31(3):325-31. doi: 10.1016/j.ejvs.2005.08.006. Epub 2005 Oct 19.
citation: Pappa E, Kontodimopoulos N, Niakas D. Validating and norming of the Greek SF-36 Health Survey. Qual Life Res. 2005 Jun;14(5):1433-8. doi: 10.1007/s11136-004-6014-y.
citation: Andreozzi GM, Cordova RM, Scomparin A, Martini R, D'Eri A, Andreozzi F; Quality of Life Working Group on Vascular Medicine of SIAPAV. Quality of life in chronic venous insufficiency. An Italian pilot study of the Triveneto Region. Int Angiol. 2005 Sep;24(3):272-7.
citation: Kim H, Hwang K, Yun SM, Kim DJ. Usage of Epinephrine Mixed With Lidocaine in Plastic Surgery. J Craniofac Surg. 2020 May/Jun;31(3):791-793. doi: 10.1097/SCS.0000000000006156.