Femoral Artery Block for Reduction of Tourniquet Induced Hypertension

Hospital da Luz, Portugal50 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Tourniquets Anesthesia, Conduction Anesthetics, Local Hypertension

Interventions

Femoral artery blockOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of Tourniquet Hypertension (TH)

Defined as Systolic Blood Pressure (SBP) increased \>30% after 30 minutes of tourniquet

Time frame: 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

Time frame: 30 minutes after tourniquet inflation

Systolic blood pressure 45 minutes after tourniquet inflation

SBP at 45 minutes after tourniquet inflation

Time frame: 45 minutes after tourniquet inflation

Systolic blood pressure 60 minutes after tourniquet inflation

SBP at 60 minutes after tourniquet inflation

Time frame: 60 minutes after tourniquet inflation

Systolic blood pressure 75 minutes after tourniquet inflation

SBP at 75 minutes after tourniquet inflation

Time frame: 75 minutes after tourniquet inflation

Systolic blood pressure 90 minutes after tourniquet inflation

SBP at 90 minutes after tourniquet inflation

Time frame: 90 minutes after tourniquet inflation

Systolic blood pressure 115 minutes after tourniquet inflation

SBP at 115 minutes after tourniquet inflation

Time frame: 115 minutes after tourniquet inflation

Systolic blood pressure 130 minutes after tourniquet inflation

SBP at 130 minutes after tourniquet inflation

Central Contacts

Vasyl HDS Katerenchuk

CONTACT

+351932902978 vasylktr@gmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 130 minutes after tourniquet inflation

Mean arterial pressure (MAP) 30 minutes after tourniquet inflation

MAP at 30 minutes after tourniquet inflation

Time frame: 30 minutes after tourniquet inflation

Mean arterial pressure 45 minutes after tourniquet inflation

MAP at 45 minutes after tourniquet inflation

Time frame: 45 minutes after tourniquet inflation

Mean arterial pressure 60 minutes after tourniquet inflation

MAP at 60 minutes after tourniquet inflation

Time frame: 60 minutes after tourniquet inflation

Mean arterial pressure 75 minutes after tourniquet inflation

MAP at 75 minutes after tourniquet inflation

Time frame: 75 minutes after tourniquet inflation

Mean arterial pressure 90 minutes after tourniquet inflation

MAP at 90 minutes after tourniquet inflation

Time frame: 90 minutes after tourniquet inflation

Mean arterial pressure 115 minutes after tourniquet inflation

MAP at 115 minutes after tourniquet inflation

Time frame: 115 minutes after tourniquet inflation

Mean arterial pressure 130 minutes after tourniquet inflation

MAP at 130 minutes after tourniquet inflation

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 130 minutes after tourniquet inflation

Secondary Outcomes

Isosorbide dinitrate administered for TH

mg of isosorbide dinitrate administered for TH

Time frame: 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)

Time frame: 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)

Time frame: Up to 2 hours after emergence from anesthesia