Clinical trial NCT05954689: Femoral Artery Block for Reduction of Tourniquet Induced Hypertension
Official title: Femoral Artery Block for Reduction of Tourniquet Induced Hypertension: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tourniquets
Anesthesia, Conduction
Anesthetics, Local
Hypertension
Lead sponsor: Hospital da Luz, Portugal
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Tourniquet Hypertension (TH)
timeFrame: Thought intra-operative time (after induction of anesthesia and until emergence from anesthesia)
measure: Systolic blood pressure 30 minutes after tourniquet inflation
timeFrame: 30 minutes after tourniquet inflation
measure: Systolic blood pressure 45 minutes after tourniquet inflation
timeFrame: 45 minutes after tourniquet inflation
measure: Systolic blood pressure 60 minutes after tourniquet inflation
timeFrame: 60 minutes after tourniquet inflation
measure: Systolic blood pressure 75 minutes after tourniquet inflation
timeFrame: 75 minutes after tourniquet inflation
measure: Systolic blood pressure 90 minutes after tourniquet inflation
timeFrame: 90 minutes after tourniquet inflation
measure: Systolic blood pressure 115 minutes after tourniquet inflation
timeFrame: 115 minutes after tourniquet inflation
measure: Systolic blood pressure 130 minutes after tourniquet inflation
timeFrame: 130 minutes after tourniquet inflation
measure: Mean arterial pressure (MAP) 30 minutes after tourniquet inflation
timeFrame: 30 minutes after tourniquet inflation
measure: Mean arterial pressure 45 minutes after tourniquet inflation
timeFrame: 45 minutes after tourniquet inflation
measure: Mean arterial pressure 60 minutes after tourniquet inflation
timeFrame: 60 minutes after tourniquet inflation
measure: Mean arterial pressure 75 minutes after tourniquet inflation
timeFrame: 75 minutes after tourniquet inflation
measure: Mean arterial pressure 90 minutes after tourniquet inflation
timeFrame: 90 minutes after tourniquet inflation
measure: Mean arterial pressure 115 minutes after tourniquet inflation
timeFrame: 115 minutes after tourniquet inflation
measure: Mean arterial pressure 130 minutes after tourniquet inflation
timeFrame: 130 minutes after tourniquet inflation
measure: Systolic blood pressure variation from baseline at 30 minutes after tourniquet inflation
timeFrame: 30 minutes after tourniquet inflation
measure: Systolic blood pressure variation from baseline at 45 minutes after tourniquet inflation
timeFrame: 45 minutes after tourniquet inflation
measure: Systolic blood pressure variation from baseline at 60 minutes after tourniquet inflation
timeFrame: 60 minutes after tourniquet inflation
measure: Systolic blood pressure variation from baseline at 75 minutes after tourniquet inflation
timeFrame: 75 minutes after tourniquet inflation
measure: Systolic blood pressure variation from baseline at 90 minutes after tourniquet inflation
timeFrame: 90 minutes after tourniquet inflation
measure: Systolic blood pressure variation from baseline at 115 minutes after tourniquet inflation
timeFrame: 115 minutes after tourniquet inflation
measure: Systolic blood pressure variation from baseline at 130 minutes after tourniquet inflation
timeFrame: 130 minutes after tourniquet inflation
measure: Mean arterial pressure variation from baseline at 30 minutes after tourniquet inflation
timeFrame: 30 minutes after tourniquet inflation
measure: Mean arterial pressure variation from baseline at 45 minutes after tourniquet inflation
timeFrame: 45 minutes after tourniquet inflation
measure: Mean arterial pressure variation from baseline at 60 minutes after tourniquet inflation
timeFrame: 60 minutes after tourniquet inflation
measure: Mean arterial pressure variation from baseline at 75 minutes after tourniquet inflation
timeFrame: 75 minutes after tourniquet inflation
measure: Mean arterial pressure variation from baseline at 90 minutes after tourniquet inflation
timeFrame: 90 minutes after tourniquet inflation
measure: Mean arterial pressure variation from baseline at 115 minutes after tourniquet inflation
timeFrame: 115 minutes after tourniquet inflation
measure: Mean arterial pressure variation from baseline at 130 minutes after tourniquet inflation
timeFrame: 130 minutes after tourniquet inflation
Secondary outcomes:
measure: Isosorbide dinitrate administered for TH
timeFrame: Thought intra-operative time (after induction of anesthesia and until emergence from anesthesia) )
measure: Numerical verbal pain scores
timeFrame: Up to 2 hours after emergence from anesthesia
measure: Patient post-operative satisfaction
timeFrame: Up to 2 hours after emergence from anesthesia
Other outcomes:
Locations:
Study officials:
affiliation: Hospital da Luz, Lisboa
name: Ana Filipa Duarte
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.