Femoral Artery Block for Reduction of Tourniquet Induced Hypertension

NCT05954689 | Unknown

• 1 other identifier: U1111-1293-7325
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Tourniquets; Anesthesia, Conduction; Anesthetics, Local; Hypertension

Outcome Measures

Primary Outcomes (29)

• 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 Outcomes (3)

• Isosorbide dinitrate administered for TH

  Thought intra-operative time (after induction of anesthesia and until emergence from anesthesia) )

• Numerical verbal pain scores

  Up to 2 hours after emergence from anesthesia

• Patient post-operative satisfaction

  Up to 2 hours after emergence from anesthesia

Study Arms (2)

Femoral artery block

EXPERIMENTAL

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

No intervention

NO INTERVENTION

Interventions

Femoral artery block OTHER

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

Femoral artery block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital da Luz, Portugal: lead

Related 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.

  PMID: 33510583 BACKGROUND

• 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.

  PMID: 36549034 BACKGROUND

• 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.

  PMID: 33431616 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ana Filipa Duarte

  Hospital da Luz, Lisboa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vasyl HDS Katerenchuk

CONTACT

+351932902978; vasylktr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anaesthesiology Resident

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 20, 2023
• Study Start: July 10, 2023
• Primary Completion: February 29, 2024
• Study Completion: May 31, 2024
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share