Femoral Artery Block for Reduction of Tourniquet Induced Hypertension

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

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 Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Anesthetics, Local; Tourniquets; Anesthesia, Conduction
• Intervention / Treatment: Other: Femoral artery block

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vasyl HDS Katerenchuk; Phone Number: +351932902978; Email: vasylktr@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention
Experimental: 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.	Other: Femoral artery block; Injection on the antero-medial side of the femoral artery of 10mL 0.5% ropivacaine with ultrasound guidance.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital da Luz, Portugal
• Investigators: Principal Investigator: Ana Filipa Duarte, Hospital da Luz, Lisboa

Publications and helpful links

General Publications

• Guo YX, Wang GY, Cheng WJ, Yan CZ, Zhao S, Li Z, Liu P, Wang XL. Activation of Opioid Receptors Attenuates Ischemia/Reperfusion Injury in Skeletal Muscle Induced by Tourniquet Placement. Mediators Inflamm. 2021 Jan 15;2021:6699499. doi: 10.1155/2021/6699499. eCollection 2021.
• Xu F, Wang X, Li Y, Gao F, Yin C, Yu J, Li W, Zhu L, Wang Q. Combined femoral artery block and femoral nerve block reduces thigh tourniquet-induced hypertension. J Clin Anesth. 2023 May;85:111039. doi: 10.1016/j.jclinane.2022.111039. Epub 2022 Dec 20.
• Wahal C, Grant SA, Gadsden J, Rambhia MT, Bullock WM. Femoral artery block (FAB) attenuates thigh tourniquet-induced hypertension: a prospective randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2021 Mar;46(3):228-232. doi: 10.1136/rapm-2020-102113. Epub 2021 Jan 11.

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2023
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: U1111-1293-7325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No