Femoral Artery Block for Reduction of Tourniquet Induced Hypertension

Study Overview
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Brief Summary
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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).

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

Conditions
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Tourniquets, Anesthesia, Conduction, Anesthetics, Local, Hypertension

Intervention / Treatment
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* Other: Femoral artery block


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Femoral artery block<br>An experienced Anesthesiologist will perform the femoral blocks, under ultrasound guidance with a linear probe and a 50mm (millimeters) or 80mm needle. No nerve stimulator will be used during the block. In both groups, femoral nerve block at the nerve sheath will be performed with 20mL (milliliters) 0.5% ropivacaine. In the interventional group, additionally to the previous block, the needle will be retracted and advanced to the antero-medial side of the femoral artery where 10mL 0.5% ropivacaine will be injected after negative aspiration. | Other: Femoral artery block<br>* Injection on the antero-medial side of the femoral artery of 10mL 0.5% ropivacaine with ultrasound guidance.<br>|
| No Intervention: No intervention<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Tourniquet Hypertension (TH) | Defined as Systolic Blood Pressure (SBP) increased >30% after 30 minutes of tourniquet | Thought intra-operative time (after induction of anesthesia and until emergence from anesthesia) | 
| Systolic blood pressure 30 minutes after tourniquet inflation | SBP at 30 minutes after tourniquet inflation | 30 minutes after tourniquet inflation | 
| Systolic blood pressure 45 minutes after tourniquet inflation | SBP at 45 minutes after tourniquet inflation | 45 minutes after tourniquet inflation | 
| Systolic blood pressure 60 minutes after tourniquet inflation | SBP at 60 minutes after tourniquet inflation | 60 minutes after tourniquet inflation | 
| Systolic blood pressure 75 minutes after tourniquet inflation | SBP at 75 minutes after tourniquet inflation | 75 minutes after tourniquet inflation | 
| Systolic blood pressure 90 minutes after tourniquet inflation | SBP at 90 minutes after tourniquet inflation | 90 minutes after tourniquet inflation | 
| Systolic blood pressure 115 minutes after tourniquet inflation | SBP at 115 minutes after tourniquet inflation | 115 minutes after tourniquet inflation | 
| Systolic blood pressure 130 minutes after tourniquet inflation | SBP at 130 minutes after tourniquet inflation | 130 minutes after tourniquet inflation | 
| Mean arterial pressure (MAP) 30 minutes after tourniquet inflation | MAP at 30 minutes after tourniquet inflation | 30 minutes after tourniquet inflation | 
| Mean arterial pressure 45 minutes after tourniquet inflation | MAP at 45 minutes after tourniquet inflation | 45 minutes after tourniquet inflation | 
| Mean arterial pressure 60 minutes after tourniquet inflation | MAP at 60 minutes after tourniquet inflation | 60 minutes after tourniquet inflation | 
| Mean arterial pressure 75 minutes after tourniquet inflation | MAP at 75 minutes after tourniquet inflation | 75 minutes after tourniquet inflation | 
| Mean arterial pressure 90 minutes after tourniquet inflation | MAP at 90 minutes after tourniquet inflation | 90 minutes after tourniquet inflation | 
| Mean arterial pressure 115 minutes after tourniquet inflation | MAP at 115 minutes after tourniquet inflation | 115 minutes after tourniquet inflation | 
| Mean arterial pressure 130 minutes after tourniquet inflation | MAP at 130 minutes after tourniquet inflation | 130 minutes after tourniquet inflation | 
| Systolic blood pressure variation from baseline at 30 minutes after tourniquet inflation | Variation of SBP compared to baseline at 30 minutes after tourniquet inflation | 30 minutes after tourniquet inflation | 
| Systolic blood pressure variation from baseline at 45 minutes after tourniquet inflation | Variation of SBP compared to baseline at 45 minutes after tourniquet inflation | 45 minutes after tourniquet inflation | 
| Systolic blood pressure variation from baseline at 60 minutes after tourniquet inflation | Variation of SBP compared to baseline at 60 minutes after tourniquet inflation | 60 minutes after tourniquet inflation | 
| Systolic blood pressure variation from baseline at 75 minutes after tourniquet inflation | Variation of SBP compared to baseline at 75 minutes after tourniquet inflation | 75 minutes after tourniquet inflation | 
| Systolic blood pressure variation from baseline at 90 minutes after tourniquet inflation | Variation of SBP compared to baseline at 90 minutes after tourniquet inflation | 90 minutes after tourniquet inflation | 
| Systolic blood pressure variation from baseline at 115 minutes after tourniquet inflation | Variation of SBP compared to baseline at 115 minutes after tourniquet inflation | 115 minutes after tourniquet inflation | 
| Systolic blood pressure variation from baseline at 130 minutes after tourniquet inflation | Variation of SBP compared to baseline at 130 minutes after tourniquet inflation | 130 minutes after tourniquet inflation | 
| Mean arterial pressure variation from baseline at 30 minutes after tourniquet inflation | Variation of MAP compared to baseline at 30 minutes after tourniquet inflation | 30 minutes after tourniquet inflation | 
| Mean arterial pressure variation from baseline at 45 minutes after tourniquet inflation | Variation of MAP compared to baseline at 45 minutes after tourniquet inflation | 45 minutes after tourniquet inflation | 
| Mean arterial pressure variation from baseline at 60 minutes after tourniquet inflation | Variation of MAP compared to baseline at 60 minutes after tourniquet inflation | 60 minutes after tourniquet inflation | 
| Mean arterial pressure variation from baseline at 75 minutes after tourniquet inflation | Variation of MAP compared to baseline at 75 minutes after tourniquet inflation | 75 minutes after tourniquet inflation | 
| Mean arterial pressure variation from baseline at 90 minutes after tourniquet inflation | Variation of MAP compared to baseline at 90 minutes after tourniquet inflation | 90 minutes after tourniquet inflation | 
| Mean arterial pressure variation from baseline at 115 minutes after tourniquet inflation | Variation of MAP compared to baseline at 115 minutes after tourniquet inflation | 115 minutes after tourniquet inflation | 
| Mean arterial pressure variation from baseline at 130 minutes after tourniquet inflation | Variation of MAP compared to baseline at 130 minutes after tourniquet inflation | 130 minutes after tourniquet inflation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isosorbide dinitrate administered for TH | mg of isosorbide dinitrate administered for TH | Thought intra-operative time (after induction of anesthesia and until emergence from anesthesia) ) | 
| Numerical verbal pain scores | Numerical 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) | Up to 2 hours after emergence from anesthesia | 
| Patient post-operative satisfaction | Patient 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) | Up to 2 hours after emergence from anesthesia |