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NCT05954689 Clinical Trial

Femoral Artery Block for Reduction of Tourniquet Induced Hypertension

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05954689
Other study ID # U1111-1293-7325
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 10, 2023
Est. completion date May 31, 2024

Study information
Verified date July 2023
Source Hospital da Luz, Portugal
Contact Vasyl HDS Katerenchuk
Phone +351932902978
Email vasylktr@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date May 31, 2024
Est. primary completion date February 29, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Femoral artery block
Injection on the antero-medial side of the femoral artery of 10mL 0.5% ropivacaine with ultrasound guidance.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospital da Luz, Portugal

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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)
Primary Systolic blood pressure 30 minutes after tourniquet inflation SBP at 30 minutes after tourniquet inflation 30 minutes after tourniquet inflation
Primary Systolic blood pressure 45 minutes after tourniquet inflation SBP at 45 minutes after tourniquet inflation 45 minutes after tourniquet inflation
Primary Systolic blood pressure 60 minutes after tourniquet inflation SBP at 60 minutes after tourniquet inflation 60 minutes after tourniquet inflation
Primary Systolic blood pressure 75 minutes after tourniquet inflation SBP at 75 minutes after tourniquet inflation 75 minutes after tourniquet inflation
Primary Systolic blood pressure 90 minutes after tourniquet inflation SBP at 90 minutes after tourniquet inflation 90 minutes after tourniquet inflation
Primary Systolic blood pressure 115 minutes after tourniquet inflation SBP at 115 minutes after tourniquet inflation 115 minutes after tourniquet inflation
Primary Systolic blood pressure 130 minutes after tourniquet inflation SBP at 130 minutes after tourniquet inflation 130 minutes after tourniquet inflation
Primary Mean arterial pressure (MAP) 30 minutes after tourniquet inflation MAP at 30 minutes after tourniquet inflation 30 minutes after tourniquet inflation
Primary Mean arterial pressure 45 minutes after tourniquet inflation MAP at 45 minutes after tourniquet inflation 45 minutes after tourniquet inflation
Primary Mean arterial pressure 60 minutes after tourniquet inflation MAP at 60 minutes after tourniquet inflation 60 minutes after tourniquet inflation
Primary Mean arterial pressure 75 minutes after tourniquet inflation MAP at 75 minutes after tourniquet inflation 75 minutes after tourniquet inflation
Primary Mean arterial pressure 90 minutes after tourniquet inflation MAP at 90 minutes after tourniquet inflation 90 minutes after tourniquet inflation
Primary Mean arterial pressure 115 minutes after tourniquet inflation MAP at 115 minutes after tourniquet inflation 115 minutes after tourniquet inflation
Primary Mean arterial pressure 130 minutes after tourniquet inflation MAP at 130 minutes after tourniquet inflation 130 minutes after tourniquet inflation
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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) )
Secondary 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
Secondary 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
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