TourniquetsNCT05954689
Femoral Artery Block for Reduction of Tourniquet Induced Hypertension
A study testing Femoral artery block in people with Tourniquets and Anesthesia, Conduction, run by Hospital da Luz, Portugal.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tourniquets, Anesthesia, Conduction, Anesthetics, Local
- What is being tested?
- Femoral artery block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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).
- Conditions
- Tourniquets, Anesthesia, Conduction, Anesthetics, Local, Hypertension
- Being tested
- Femoral artery block
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral artery blockOther
Injection on the antero-medial side of the femoral artery of 10mL 0.5% ropivacaine with ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Femoral artery block |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Tourniquet Hypertension (TH)
Defined as Systolic Blood Pressure (SBP) increased >30% after 30 minutes of tourniquet
Measured: 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
Measured: 30 minutes after tourniquet inflation
Systolic blood pressure 45 minutes after tourniquet inflation
SBP at 45 minutes after tourniquet inflation
Measured: 45 minutes after tourniquet inflation
Systolic blood pressure 60 minutes after tourniquet inflation
SBP at 60 minutes after tourniquet inflation
Measured: 60 minutes after tourniquet inflation
Systolic blood pressure 75 minutes after tourniquet inflation
SBP at 75 minutes after tourniquet inflation
Measured: 75 minutes after tourniquet inflation
Systolic blood pressure 90 minutes after tourniquet inflation
SBP at 90 minutes after tourniquet inflation
Measured: 90 minutes after tourniquet inflation
Systolic blood pressure 115 minutes after tourniquet inflation
SBP at 115 minutes after tourniquet inflation
Measured: 115 minutes after tourniquet inflation
Systolic blood pressure 130 minutes after tourniquet inflation
SBP at 130 minutes after tourniquet inflation
Measured: 130 minutes after tourniquet inflation
Mean arterial pressure (MAP) 30 minutes after tourniquet inflation
MAP at 30 minutes after tourniquet inflation
Measured: 30 minutes after tourniquet inflation
Mean arterial pressure 45 minutes after tourniquet inflation
MAP at 45 minutes after tourniquet inflation
Measured: 45 minutes after tourniquet inflation
Mean arterial pressure 60 minutes after tourniquet inflation
MAP at 60 minutes after tourniquet inflation
Measured: 60 minutes after tourniquet inflation
Mean arterial pressure 75 minutes after tourniquet inflation
MAP at 75 minutes after tourniquet inflation
Measured: 75 minutes after tourniquet inflation
Mean arterial pressure 90 minutes after tourniquet inflation
MAP at 90 minutes after tourniquet inflation
Measured: 90 minutes after tourniquet inflation
Mean arterial pressure 115 minutes after tourniquet inflation
MAP at 115 minutes after tourniquet inflation
Measured: 115 minutes after tourniquet inflation
Mean arterial pressure 130 minutes after tourniquet inflation
MAP at 130 minutes after tourniquet inflation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 130 minutes after tourniquet inflation
Secondary outcomes (3)
Isosorbide dinitrate administered for TH
mg of isosorbide dinitrate administered for TH
Measured: Thought intra-operative time (after induction of anesthesia and until emergence from anesthesia) )
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)
Measured: Up to 2 hours after emergence from anesthesia
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)
Measured: Up to 2 hours after emergence from anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start10 Jul 2023 (estimated)
- Primary completion29 Feb 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TourniquetsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital da Luz, Portugal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasyl Katerenchuk, Hospital da Luz, Portugal
- Investigators
- Ana Filipa Duarte, Principal investigator, Hospital da Luz Lisboa, Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954689
- Sponsor's protocol ID
- U1111-1293-7325
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33510583Xu 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.
PubMed 36549034Wahal 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.
PubMed 33431616
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Artery Block for Reduction of Tourniquet Induced Hypertension: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05954689
- Acronym / sponsor ID
- U1111-1293-7325
- Conditions
- Tourniquets, Anesthesia, Conduction, Anesthetics, Local, Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital da Luz, PortugalUniversity, hospital or other
- Study start
- 10 Jul 2023 (estimated)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral artery block | Experimental | Other: Femoral artery blockAn 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. |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femoral artery blockInjection on the antero-medial side of the femoral artery of 10mL 0.5% ropivacaine with ultrasound guidance. | Other | Femoral artery block |
Primary outcome
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 30 minutes after tourniquet inflation
Time frame: 30 minutes after tourniquet inflation
SBP at 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
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
Systolic blood pressure 90 minutes after tourniquet inflation
Time frame: 90 minutes after tourniquet inflation
SBP at 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
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 (MAP) 30 minutes after tourniquet inflation
Time frame: 30 minutes after tourniquet inflation
MAP at 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
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 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 115 minutes after tourniquet inflation
Time frame: 115 minutes after tourniquet inflation
MAP at 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
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 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 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
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 90 minutes after tourniquet inflation
Time frame: 90 minutes after tourniquet inflation
Variation of SBP compared to baseline at 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
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
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
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 60 minutes after tourniquet inflation
Time frame: 60 minutes after tourniquet inflation
Variation of MAP compared to baseline at 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
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
3 secondary outcomes
Isosorbide dinitrate administered for TH
Time frame: 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
Patient post-operative satisfaction
Time frame: Up to 2 hours after emergence from anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Background: PubMed 33510583Guo 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.
- Background: PubMed 36549034Xu 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.
- Background: PubMed 33431616Wahal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Filipa Duarte principal investigator
Hospital da Luz Lisboa, Portugal
Questions about this trial
What is this clinical trial studying?
A study testing Femoral artery block in people with Tourniquets and Anesthesia, Conduction, run by Hospital da Luz, Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vasyl HDS Katerenchuk (+351932902978, vasylktr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Tourniquet Hypertension (TH) (time frame: Thought intra-operative time (after induction of anesthesia and until emergence from anesthesia)). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05954689, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.