Femoral Artery Block for Reduction of Tourniquet Induced Hypertension

Not Applicable

Not yet recruiting

• Conditions: Anesthetics, Local; Anesthesia, Conduction; Hypertension; Tourniquets
• Interventions: Other: Femoral artery block

• Registration Number: NCT05954689
• Lead Sponsor: Hospital da Luz, Portugal

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-06
• Study Start: 2023-07-10
• Study First Submitted QC: 2023-07-13
• Last Update Submitted: 2023-07-13
• Study First Posted: 2023-07-20
• Last Update Posted: 2023-07-20
• Primary Completion: 2024-02-29
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femoral artery block	Femoral artery block	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.

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure 45 minutes after tourniquet inflation	45 minutes after tourniquet inflation	SBP at 45 minutes after tourniquet inflation
Mean arterial pressure (MAP) 30 minutes after tourniquet inflation	30 minutes after tourniquet inflation	MAP at 30 minutes after tourniquet inflation
Systolic blood pressure 60 minutes after tourniquet inflation	60 minutes after tourniquet inflation	SBP at 60 minutes after tourniquet inflation
Systolic blood pressure 75 minutes after tourniquet inflation	75 minutes after tourniquet inflation	SBP at 75 minutes after tourniquet inflation
Mean arterial pressure 45 minutes after tourniquet inflation	45 minutes after tourniquet inflation	MAP at 45 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 45 minutes after tourniquet inflation	45 minutes after tourniquet inflation	Variation of SBP compared to baseline at 45 minutes after tourniquet inflation
Systolic blood pressure 115 minutes after tourniquet inflation	115 minutes after tourniquet inflation	SBP at 115 minutes after tourniquet inflation
Systolic blood pressure 130 minutes after tourniquet inflation	130 minutes after tourniquet inflation	SBP at 130 minutes after tourniquet inflation
Mean arterial pressure 130 minutes after tourniquet inflation	130 minutes after tourniquet inflation	MAP at 130 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 60 minutes after tourniquet inflation	60 minutes after tourniquet inflation	Variation of SBP compared to baseline at 60 minutes after tourniquet inflation
Mean arterial pressure variation from baseline at 30 minutes after tourniquet inflation	30 minutes after tourniquet inflation	Variation of MAP compared to baseline at 30 minutes after tourniquet inflation
Systolic blood pressure 30 minutes after tourniquet inflation	30 minutes after tourniquet inflation	SBP at 30 minutes after tourniquet inflation
Mean arterial pressure 75 minutes after tourniquet inflation	75 minutes after tourniquet inflation	MAP at 75 minutes after tourniquet inflation
Mean arterial pressure 90 minutes after tourniquet inflation	90 minutes after tourniquet inflation	MAP at 90 minutes after tourniquet inflation
Mean arterial pressure variation from baseline at 60 minutes after tourniquet inflation	60 minutes after tourniquet inflation	Variation of MAP compared to baseline at 60 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 90 minutes after tourniquet inflation	90 minutes after tourniquet inflation	SBP at 90 minutes after tourniquet inflation
Mean arterial pressure 60 minutes after tourniquet inflation	60 minutes after tourniquet inflation	MAP at 60 minutes after tourniquet inflation
Mean arterial pressure 115 minutes after tourniquet inflation	115 minutes after tourniquet inflation	MAP at 115 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 75 minutes after tourniquet inflation	75 minutes after tourniquet inflation	Variation of SBP compared to baseline at 75 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 115 minutes after tourniquet inflation	115 minutes after tourniquet inflation	Variation of SBP compared to baseline at 115 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 130 minutes after tourniquet inflation	130 minutes after tourniquet inflation	Variation of SBP compared to baseline at 130 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 30 minutes after tourniquet inflation	30 minutes after tourniquet inflation	Variation of SBP compared to baseline at 30 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 90 minutes after tourniquet inflation	90 minutes after tourniquet inflation	Variation of SBP compared to baseline at 90 minutes after tourniquet inflation
Mean arterial pressure variation from baseline at 45 minutes after tourniquet inflation	45 minutes after tourniquet inflation	Variation of MAP compared to baseline at 45 minutes after tourniquet inflation
Mean arterial pressure variation from baseline at 75 minutes after tourniquet inflation	75 minutes after tourniquet inflation	Variation of MAP compared to baseline at 75 minutes after tourniquet inflation
Mean arterial pressure variation from baseline at 90 minutes after tourniquet inflation	90 minutes after tourniquet inflation	Variation of MAP compared to baseline at 90 minutes after tourniquet inflation
Mean arterial pressure variation from baseline at 115 minutes after tourniquet inflation	115 minutes after tourniquet inflation	Variation of MAP compared to baseline at 115 minutes after tourniquet inflation
Mean arterial pressure variation from baseline at 130 minutes after tourniquet inflation	130 minutes after tourniquet inflation	Variation of MAP compared to baseline at 130 minutes after tourniquet inflation

Secondary Outcome Measures

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