Femoral Artery Block for Reduction of Tourniquet Induced Hypertension

NCT ID: NCT05954689

Last Updated: 2023-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2024-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tourniquets Anesthesia, Conduction Anesthetics, Local Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Femoral artery block

Intervention Type OTHER

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

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Femoral artery block

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital da Luz, Portugal

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Vasyl Katerenchuk

Anaesthesiology Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ana Filipa Duarte

Role: PRINCIPAL_INVESTIGATOR

Hospital da Luz, Lisboa

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Vasyl HDS Katerenchuk

Role: CONTACT

+351932902978

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 33510583 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36549034 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33431616 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1293-7325

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

IPACK Block in Total Knee Arthroplasty
NCT03692858 UNKNOWN PHASE2