Femoral Artery Block for Reduction of Tourniquet Induced Hypertension

July 13, 2023 updated by: Vasyl Katerenchuk, Hospital da Luz, Portugal

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Thought intra-operative time (after induction of anesthesia and until emergence from anesthesia)
Systolic blood pressure 30 minutes after tourniquet inflation
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Isosorbide dinitrate administered for TH
Time Frame: Thought intra-operative time (after induction of anesthesia and until emergence from anesthesia) )
mg of isosorbide dinitrate administered for TH
Thought intra-operative time (after induction of anesthesia and until emergence from anesthesia) )
Numerical verbal pain scores
Time Frame: Up to 2 hours after emergence from anesthesia
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
Time Frame: Up to 2 hours after emergence from anesthesia
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital da Luz, Portugal

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ana Filipa Duarte, Hospital da Luz, Lisboa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 10, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 29, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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