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NCT Number: NCT04844372

Impact of Regional Anesthesia on Blood Pressure in Lower Limb Traumatism

This study aims to compare the hemodynamic impact of two anaesthetic strategies 'Regional anesthesia' versus 'General anesthesia' in leg and ankle fractures surgery.

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Key information

Conditions

Fracture, Ankle Ankle Fractures Ankle Injuries Fracture Leg Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

Leg and/or ankle surgery is frequently performed under General Anesthesia (GA). GA is frequently associated with a high risk of hypotension with significant consequences.

Regional anesthesia could be an interesting alternative to GA in order to limit hemodynamic consequences, especially in elderly patients.

Furthermore, in the current state of Covid 19 crisis, regional anesthesia could provide solutions in preserving drugs for GA and exposing less medical staff on patient's airway.

Currently, unlike neuraxial anesthesia, few data deal with impact of peripheral RA and hemodynamic consequences.

The investigators hypothesize that the use of Regional anesthesia reduces the use of intraoperative vasopressor.

After ethical committee approval, a retrospective cohort of patients with lower limb traumatism, in Montpellier's University Hospital, was analyzed from 2016 to 2020. An informational note was given to all patients participating to the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I - IV
  • Ankle and/or leg fracture
  • Operated between january 2016 and december 2020 at Montpellier

Exclusion criteria

  • age < 18 years

Treatment and study plan

Primary outcomes

  1. use of vasopressors

    Time frame: during surgery

    use of vasopressors during surgery

Secondary outcomes

  1. Total dose of vasoconstrictor

    Time frame: during surgery

    Total dose of vasoconstrictor administered

  2. Duration of peroperative hypotension

    Time frame: during surgery

    Duration of peroperative hypotension

  3. Post-operative complications

    Time frame: up to 7 days

    Nausea/vomiting ; Cardiovascular complications ( dysrhythmias, ischaemia, Complications related to regional anesthesia (sciatic nerve paralysis, femoral) haematoma thromboembolism, sepsis, postoperative cognitive disorders);

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Impact of Regional Anesthesia on Blood Pressure in Lower Limb Traumatism : IRB (Impact of Regional Anesthesia on Blood Pressure)

Acronym: IRB

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2021
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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