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Femoral Artery Block for Reduction of Tourniquet Induced Hypertension

Femoral Artery Block for Reduction of Tourniquet Induced Hypertension: a Randomised Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05954689
Enrollment
50
Registered
2023-07-20
Start date
2023-07-10
Completion date
2024-05-31
Last updated
2023-07-20

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

Conditions

Anesthesia, Conduction, Anesthetics, Local, Hypertension, Tourniquets

Brief 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).

Interventions

OTHERFemoral artery block

Injection on the antero-medial side of the femoral artery of 10mL 0.5% ropivacaine with ultrasound guidance.

Sponsors

Hospital da Luz, Portugal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean arterial pressure variation from baseline at 130 minutes after tourniquet inflation130 minutes after tourniquet inflationVariation of MAP compared to baseline at 130 minutes after tourniquet inflation
Mean arterial pressure variation from baseline at 75 minutes after tourniquet inflation75 minutes after tourniquet inflationVariation of MAP compared to baseline at 75 minutes after tourniquet inflation
Mean arterial pressure variation from baseline at 90 minutes after tourniquet inflation90 minutes after tourniquet inflationVariation of MAP compared to baseline at 90 minutes after tourniquet inflation
Mean arterial pressure variation from baseline at 115 minutes after tourniquet inflation115 minutes after tourniquet inflationVariation of MAP compared to baseline at 115 minutes after tourniquet inflation
Incidence of Tourniquet Hypertension (TH)Thought intra-operative time (after induction of anesthesia and until emergence from anesthesia)Defined as Systolic Blood Pressure (SBP) increased \>30% after 30 minutes of tourniquet
Systolic blood pressure 30 minutes after tourniquet inflation30 minutes after tourniquet inflationSBP at 30 minutes after tourniquet inflation
Systolic blood pressure 45 minutes after tourniquet inflation45 minutes after tourniquet inflationSBP at 45 minutes after tourniquet inflation
Systolic blood pressure 60 minutes after tourniquet inflation60 minutes after tourniquet inflationSBP at 60 minutes after tourniquet inflation
Systolic blood pressure 75 minutes after tourniquet inflation75 minutes after tourniquet inflationSBP at 75 minutes after tourniquet inflation
Systolic blood pressure 90 minutes after tourniquet inflation90 minutes after tourniquet inflationSBP at 90 minutes after tourniquet inflation
Systolic blood pressure 115 minutes after tourniquet inflation115 minutes after tourniquet inflationSBP at 115 minutes after tourniquet inflation
Systolic blood pressure 130 minutes after tourniquet inflation130 minutes after tourniquet inflationSBP at 130 minutes after tourniquet inflation
Mean arterial pressure (MAP) 30 minutes after tourniquet inflation30 minutes after tourniquet inflationMAP at 30 minutes after tourniquet inflation
Mean arterial pressure 45 minutes after tourniquet inflation45 minutes after tourniquet inflationMAP at 45 minutes after tourniquet inflation
Mean arterial pressure 60 minutes after tourniquet inflation60 minutes after tourniquet inflationMAP at 60 minutes after tourniquet inflation
Mean arterial pressure 75 minutes after tourniquet inflation75 minutes after tourniquet inflationMAP at 75 minutes after tourniquet inflation
Mean arterial pressure 90 minutes after tourniquet inflation90 minutes after tourniquet inflationMAP at 90 minutes after tourniquet inflation
Mean arterial pressure 115 minutes after tourniquet inflation115 minutes after tourniquet inflationMAP at 115 minutes after tourniquet inflation
Mean arterial pressure 130 minutes after tourniquet inflation130 minutes after tourniquet inflationMAP at 130 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 30 minutes after tourniquet inflation30 minutes after tourniquet inflationVariation of SBP compared to baseline at 30 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 45 minutes after tourniquet inflation45 minutes after tourniquet inflationVariation of SBP compared to baseline at 45 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 60 minutes after tourniquet inflation60 minutes after tourniquet inflationVariation of SBP compared to baseline at 60 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 75 minutes after tourniquet inflation75 minutes after tourniquet inflationVariation of SBP compared to baseline at 75 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 90 minutes after tourniquet inflation90 minutes after tourniquet inflationVariation of SBP compared to baseline at 90 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 115 minutes after tourniquet inflation115 minutes after tourniquet inflationVariation of SBP compared to baseline at 115 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 130 minutes after tourniquet inflation130 minutes after tourniquet inflationVariation of SBP compared to baseline at 130 minutes after tourniquet inflation
Mean arterial pressure variation from baseline at 30 minutes after tourniquet inflation30 minutes after tourniquet inflationVariation of MAP compared to baseline at 30 minutes after tourniquet inflation
Mean arterial pressure variation from baseline at 45 minutes after tourniquet inflation45 minutes after tourniquet inflationVariation of MAP compared to baseline at 45 minutes after tourniquet inflation
Mean arterial pressure variation from baseline at 60 minutes after tourniquet inflation60 minutes after tourniquet inflationVariation of MAP compared to baseline at 60 minutes after tourniquet inflation

Secondary

MeasureTime frameDescription
Numerical verbal pain scoresUp to 2 hours after emergence from anesthesiaNumerical verbal pain scores (from 0 to 10, 10 meaning higher pain) assessed 1 hour after emergence of anesthesia in the post-operative care unit (PACU)
Patient post-operative satisfactionUp to 2 hours after emergence from anesthesiaPatient post-operative satisfaction with pain treatment measured 1 hour after emergence of anesthesia in the post-operative care unit using a 5-point Likert-scale, namely: 1 - very unsatisfied, 2 - unsatisfied, 3 - neutral, 4 - satisfied, 5 - very satisfied (with higher scores meaning a higher outcome)
Isosorbide dinitrate administered for THThought intra-operative time (after induction of anesthesia and until emergence from anesthesia) )mg of isosorbide dinitrate administered for TH

Contacts

Primary ContactVasyl HDS Katerenchuk
vasylktr@gmail.com+351932902978

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026