PainNCT03475641
Femoral Nerve Blockade in Endovenous Laser
A study testing Femoral nerve blockade and The current standard treatment in people with Pain, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Varicose veins affect a majority of adult population in the western world. They decrease quality of life and may also cause venous ulcers. Therefore varicose vein treatments are justified. Currently endovenous thermal ablation is a treatment of choice for varicose veins. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Femoral nerve blockade and The current standard treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFinland
- Study dates
- 13 Mar 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Great saphenous vein insufficiency
- CEAP class 2-4
Who cannot join
- Neurological diseases
- Pregnancy
- CEAP 5-6
- BMI>40
- Allergy to lidocain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Femoral Nerve Blockade in Endovenous Laser During Varicose Vein Treatment
Varicose veins affect a majority of adult population in the western world. They decrease quality of life and may also cause venous ulcers. Therefore varicose vein treatments are justified. Currently endovenous thermal ablation is a treatment of choice for varicose veins. At the outpatient setting, however, treating both limbs at the same time may be painful to the patient especially, if simultaneous phlebectomies are performed.
The study aims to evaluate, if femoral nerve blockade can significantly decrease pain during the procedure without prolonging the stay in the hospital.
Read the detailed description
Varicose veins affect a majority of adult population in the western world. They decrease quality of life and may also cause venous ulcers. Therefore varicose vein treatments are justified.
Thanks to technical advancement open surgery has been replaced By endovenous means. Currently endovenous thermal ablation is a golden standard for main trunk disease. For efficient patient and procedure flow majority of thermal ablations are performed at the outpatient setting. However, if patient is suffering from significant varicose veins, treating both legs, may be unpleasant to the patient.
Aim of the study is, whether addition of femoral nerve blockade to the tumescent anesthesia can decrease pain during the procedure without prolonging the stay in the hospital.
- Conditions
- Pain
- Being tested
- Femoral nerve blockade, The current standard treatment
- Keywords
- pain, femoral nerve blockade, varicose vein
- Medical subject headings
- Pain, Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral nerve blockadeDrug
The femoral nerve blockade with lidocain is combined to the tumescent anesthesia.
The current standard treatmentProcedure or surgery
Tumescent anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| The current standard anesthesia | Active comparator | Standard treatment during procedure Receives: Procedure: The current standard treatment |
| Femoral nerve blockade | Experimental | Femoral nerve blockade added to the standard treatment. Receives: Drug: Femoral nerve blockade; Procedure: The current standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain analysed by Numeric Rating Scale during operation. Scale ranges from 0-10. 0 describes painless situation and 10 the worst imaginable pain ever.
Measured: Peri-procedural
Secondary outcomes (4)
Pain
Pain analysed by Numeric Rating Scale during application of anesthesia. Scale ranges from 0-10. 0 describes painless situation and 10 the worst imaginable pain ever.
Measured: Pre-procedural
Pain
Pain analysed by Numeric Rating Scale at 1h after the procedure. Scale ranges from 0-10. 0 describes painless situation and 10 the worst imaginable pain ever.
Measured: 1h after the procedure
Motoric paresthesias of the femoral nerve
Ability to move knee and ankle at the end of the procedure analysed by Bromage scale. The scale measures motoric functioning of the femoral nerve: 0 = full flexion of ankle and knee possible, 1= knee flexion possible 2= ankle flexion possible, 3= impossible to move either knee or ankle
Measured: After the phlebectomies
Motoric paresthesias
Ability to move knee and ankle one hour after the procedure analysed by Bromage scale. The scale measures motoric functioning of the femoral nerve: 0 = full flexion of ankle and knee possible, 1= knee flexion possible 2= ankle flexion possible, 3= impossible to move either knee or ankle
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start13 Mar 2017
- Primary completion15 Oct 2019
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maarit Venermo, Helsinki University Central Hospital
- Investigators
- Anders Alback, MD,PhD, Study chair, Head of DepratmentKaroliina H Halmesmaki, MD, PhD, Principal investigator, Head of Venous Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475641
- Sponsor's protocol ID
- FEMINE
- Status last verified
- Aug 2022
- First submitted
- 13 Oct 2017
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share the data is made after follow-up
Publications
Hurmerinta-Kurkijarvi O, Weselius EM, Halmesmaki K, Vikatmaa P, Vikatmaa L, Venermo M. Femoral nerve blockade during endovenous laser ablation of great saphenous vein decreases pain but does not affect the use of opioids during the procedure. J Vasc Surg Venous Lymphat Disord. 2023 Sep;11(5):921-927. doi: 10.1016/j.jvsv.2023.04.007. Epub 2023 May 2.
PubMed 37142055
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Nerve Blockade in Endovenous Laser During Varicose Vein Treatment
- ClinicalTrials.gov ID
- NCT03475641
- Acronym / sponsor ID
- FEMINE
- Conditions
- Pain
- Keywords
- pain, femoral nerve blockade, varicose vein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Varicose veins affect a majority of adult population in the western world. They decrease quality of life and may also cause venous ulcers. Therefore varicose vein treatments are justified. Currently endovenous thermal ablation is a treatment of choice for varicose veins. At the outpatient setting, however, treating both limbs at the same time may be painful to the patient especially, if simultaneous phlebectomies are performed.
The study aims to evaluate, if femoral nerve blockade can significantly decrease pain during the procedure without prolonging the stay in the hospital.
Detailed description
Varicose veins affect a majority of adult population in the western world. They decrease quality of life and may also cause venous ulcers. Therefore varicose vein treatments are justified.
Thanks to technical advancement open surgery has been replaced By endovenous means. Currently endovenous thermal ablation is a golden standard for main trunk disease. For efficient patient and procedure flow majority of thermal ablations are performed at the outpatient setting. However, if patient is suffering from significant varicose veins, treating both legs, may be unpleasant to the patient.
Aim of the study is, whether addition of femoral nerve blockade to the tumescent anesthesia can decrease pain during the procedure without prolonging the stay in the hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The current standard anesthesia | Active comparator | Procedure: The current standard treatmentStandard treatment during procedure |
| Femoral nerve blockade | Experimental | Drug: Femoral nerve blockade, Procedure: The current standard treatmentFemoral nerve blockade added to the standard treatment. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Great saphenous vein insufficiency
- CEAP class 2-4
Key exclusion criteria (5 listed)
- Neurological diseases
- Pregnancy
- CEAP 5-6
- BMI>40
- Allergy to lidocain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femoral nerve blockadeThe femoral nerve blockade with lidocain is combined to the tumescent anesthesia. | Drug | Femoral nerve blockade |
| The current standard treatmentTumescent anesthesia. | Procedure or surgery | Femoral nerve blockade, The current standard anesthesia |
Primary outcome
Pain
Time frame: Peri-procedural
Pain analysed by Numeric Rating Scale during operation. Scale ranges from 0-10. 0 describes painless situation and 10 the worst imaginable pain ever.
4 secondary outcomes
Pain
Time frame: Pre-procedural
Pain
Time frame: 1h after the procedure
Motoric paresthesias of the femoral nerve
Time frame: After the phlebectomies
Motoric paresthesias
Time frame: through study completion, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Derived from this study: PubMed 37142055Hurmerinta-Kurkijarvi O, Weselius EM, Halmesmaki K, Vikatmaa P, Vikatmaa L, Venermo M. Femoral nerve blockade during endovenous laser ablation of great saphenous vein decreases pain but does not affect the use of opioids during the procedure. J Vasc Surg Venous Lymphat Disord. 2023 Sep;11(5):921-927. doi: 10.1016/j.jvsv.2023.04.007. Epub 2023 May 2.
- Individual participant dataSharing planned: Undecided. The decision to share the data is made after follow-up
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Alback, MD,PhD study chair
Head of Depratment
Karoliina H Halmesmaki, MD, PhD principal investigator
Head of Venous Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral nerve blockade and The current standard treatment in people with Pain, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Peri-procedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03475641, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.