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Clinical Trials/NCT05954689
NCT05954689
Not yet recruiting
Not Applicable

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

Hospital da Luz, Portugal0 sites50 target enrollmentStarted: July 10, 2023Last updated:
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ConditionsTourniquetsAnesthesia, ConductionAnesthetics, LocalHypertension

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Hospital da Luz, Portugal
Enrollment
50
Primary Endpoint
Systolic blood pressure 45 minutes after tourniquet inflation
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Systolic blood pressure 45 minutes after tourniquet inflation

Time Frame: 45 minutes after tourniquet inflation

SBP at 45 minutes after tourniquet inflation

Mean arterial pressure (MAP) 30 minutes after tourniquet inflation

Time Frame: 30 minutes after tourniquet inflation

MAP at 30 minutes after tourniquet inflation

Systolic blood pressure 60 minutes after tourniquet inflation

Time Frame: 60 minutes after tourniquet inflation

SBP at 60 minutes after tourniquet inflation

Systolic blood pressure 75 minutes after tourniquet inflation

Time Frame: 75 minutes after tourniquet inflation

SBP at 75 minutes after tourniquet inflation

Mean arterial pressure 45 minutes after tourniquet inflation

Time Frame: 45 minutes after tourniquet inflation

MAP at 45 minutes after tourniquet inflation

Systolic blood pressure variation from baseline at 45 minutes after tourniquet inflation

Time Frame: 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

Time Frame: 115 minutes after tourniquet inflation

SBP at 115 minutes after tourniquet inflation

Systolic blood pressure 130 minutes after tourniquet inflation

Time Frame: 130 minutes after tourniquet inflation

SBP at 130 minutes after tourniquet inflation

Mean arterial pressure 130 minutes after tourniquet inflation

Time Frame: 130 minutes after tourniquet inflation

MAP at 130 minutes after tourniquet inflation

Systolic blood pressure variation from baseline at 60 minutes after tourniquet inflation

Time Frame: 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

Time Frame: 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

Time Frame: 30 minutes after tourniquet inflation

SBP at 30 minutes after tourniquet inflation

Mean arterial pressure 75 minutes after tourniquet inflation

Time Frame: 75 minutes after tourniquet inflation

MAP at 75 minutes after tourniquet inflation

Mean arterial pressure 90 minutes after tourniquet inflation

Time Frame: 90 minutes after tourniquet inflation

MAP at 90 minutes after tourniquet inflation

Mean arterial pressure variation from baseline at 60 minutes after tourniquet inflation

Time Frame: 60 minutes after tourniquet inflation

Variation of MAP compared to baseline at 60 minutes after tourniquet inflation

Incidence of Tourniquet Hypertension (TH)

Time Frame: 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

Time Frame: 90 minutes after tourniquet inflation

SBP at 90 minutes after tourniquet inflation

Mean arterial pressure 60 minutes after tourniquet inflation

Time Frame: 60 minutes after tourniquet inflation

MAP at 60 minutes after tourniquet inflation

Mean arterial pressure 115 minutes after tourniquet inflation

Time Frame: 115 minutes after tourniquet inflation

MAP at 115 minutes after tourniquet inflation

Systolic blood pressure variation from baseline at 75 minutes after tourniquet inflation

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 130 minutes after tourniquet inflation

Variation of MAP compared to baseline at 130 minutes after tourniquet inflation

Secondary Outcomes

  • 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)

Investigators

Sponsor
Hospital da Luz, Portugal
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Vasyl Katerenchuk

Anaesthesiology Resident

Hospital da Luz, Portugal

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