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Impact of Regional Anesthesia on Blood Pressure in Lower Limb Traumatism

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04844372
Acronym
IRB
Enrollment
250
Registered
2021-04-14
Start date
2021-03-01
Completion date
2022-03-29
Last updated
2022-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture, Ankle, Fracture Leg

Keywords

Surgery for Ankle and/or leg fracture

Brief summary

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

Detailed description

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.

Interventions

None listed

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\- age \< 18 years

Design outcomes

Primary

MeasureTime frameDescription
use of vasopressorsduring surgeryuse of vasopressors during surgery

Secondary

MeasureTime frameDescription
Total dose of vasoconstrictorduring surgeryTotal dose of vasoconstrictor administered
Duration of peroperative hypotensionduring surgeryDuration of peroperative hypotension
Post-operative complicationsup to 7 daysNausea/vomiting ; Cardiovascular complications ( dysrhythmias, ischaemia, Complications related to regional anesthesia (sciatic nerve paralysis, femoral) haematoma thromboembolism, sepsis, postoperative cognitive disorders);

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026