"Improving laser treatment of Varicose Veins"

Tumescent Anaesthesia in Endovenous Laser Ablation of Varicose Veins: A Randomised Controlled Trial of a Buffered Tumescent Solution - RCT of Buffered Tumescent Anaesthesia for EVLA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005575-16-GB

Enrollment

100

Registered

2011-12-12

Start date

2011-12-21

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain of injection of a tumescent anaesthetic solution used during EndoVenous Laser Ablation of Varicose Veins.

Interventions

Trade Name: Sodium Bicarbonate Injection BP 8.4% w/v Product Name: Sodium Bicarbonate Injection BP 8.4% w/v Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: 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.;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.;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).	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: 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.;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.;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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Secondary

Measure	Time frame
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;Timepoint(s) of evaluation of this end point: As above	—

Measure

Time frame

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;Timepoint(s) of evaluation of this end point: As above

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026