- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01550094
A Comparison of Two Injection Locations in Obese Patients Having Lower Leg/Foot Surgery
Evaluation of Ultrasound-Guided Popliteal Sciatic Nerve Blockade in the Severely and Morbidly Obese Populations
Studieoversigt
Status
Detaljeret beskrivelse
The purpose of this study is to compare two different techniques for placement of nerve blocks for your foot or ankle procedure. A nerve block involves injecting numbing medications around a nerve to decrease pain after surgery. An ultrasound machine is often used to help see the nerve before injecting the numbing medicine. When an ultrasound machine is used during a block it is called an ultrasound-guided block.
Many studies of ultrasound-guided nerve blocks have involved mostly thin patients, especially from foreign countries. This study is different because the investigators are looking at patients living in America with a body mass index (a measure of the amount of body fat a person has) of more than 35.
The Sciatic nerve is a large nerve that provides most of the feeling and all of the movement to the foot and ankle. The nerve travels under the back of the leg, and splits into two smaller nerves slightly above the knee.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70121
- Ochsner Clinic Foundation
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients ≥ 18 years of age undergoing unilateral foot and/or ankle surgery
- Severe or morbid obesity, defined as a BMI of 35-39 or ≥ 40, respectively
- ASA status I-IV
- Ability to understand and provide informed consent
Exclusion Criteria:
- True allergy, not sensitivity, to any of the following substances:
Local Anesthetics Midazolam Fentanyl Hydromorphone Propofol
- Pregnancy
- Evidence of infection at or near the proposed needle insertion site
- Unstable or undetermined neurologic disease of the lower extremity
- Chronic pain patients
- Patient refusal or inability to provide informed consent
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jose Soberon, MD, Ochsner Health System
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2011.191.B (Anden identifikator: Ochnser Clinic Foundation Institutional Review Board)
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