UnknownNot Applicable

Femoral Artery Block for Reduction of Tourniquet Induced Hypertension

50 participantsStarted 2023-07-10

Plain-language summary

A randomised controlled trial to assess the impact of femoral artery block on the incidence of tourniquet hypertension in patients receiving cruciate ligament surgery with \> 30 minutes of tourniquet under combined anaesthesia (balanced general anaesthesia and femoral nerve blocks).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical status I to III * Receiving cruciate ligament surgery with \> 30 minutes of tourniquet * Combined anesthesia (balanced general anesthesia and femoral nerve block) Exclusion Criteria: * Nerve block contraindications (block site infection, allergic to local anesthetic) * Tourniquet contraindications (peripheral vascular disease or neuropathy, previous arterial bypass graft) * Tourniquet inflation time \< 30 min * Patient refusal * Pregnant patients * Patients with a active psychiatric disease.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Tourniquet Hypertension (TH)

Timeframe: Thought intra-operative time (after induction of anesthesia and until emergence from anesthesia)

Systolic blood pressure 30 minutes after tourniquet inflation

Timeframe: 30 minutes after tourniquet inflation

Systolic blood pressure 45 minutes after tourniquet inflation

Timeframe: 45 minutes after tourniquet inflation

Systolic blood pressure 60 minutes after tourniquet inflation

Timeframe: 60 minutes after tourniquet inflation

Systolic blood pressure 75 minutes after tourniquet inflation

Timeframe: 75 minutes after tourniquet inflation

Systolic blood pressure 90 minutes after tourniquet inflation

Timeframe: 90 minutes after tourniquet inflation

Systolic blood pressure 115 minutes after tourniquet inflation

Trial details

NCT IDNCT05954689

SponsorHospital da Luz, Portugal

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-29

Contact for this trial

Vasyl HDS Katerenchuk

+351932902978 vasylktr@gmail.com

View on ClinicalTrials.gov More Tourniquets trials