Accuracy of the Thoracic Epidural Catheter Insertion Confirmed by Fluoroscopic Imaging
Determining the Accuracy of Thoracic Epidural Continuous Catheter Insertion With Confirmatory Fluoroscopic Imaging
In patients scheduled for thoracic surgery or upper abdominal surgery, investigators will determine the accuracy of the epidural catheter placement by using fluoroscopic imaging.
Previous studies have drawn contradictory conclusions based the potential flaw assumption of 100% success rate for correct epidural catheter placement in the thoracic region.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Thoracic epidural analgesia (TEA) is a key tool in management of pain after thoracic or upper abdominal surgery. TEA optimizes pain relief while minimizing the use of systemic opioids, thus reducing the duration of postoperative ileus. TEA also attenuates surgical stress response and allows for early mobilization. Despite all the touted benefits of TEA, much controversy limits its use for post surgical pain due to fear of exceedingly rare, if not entirely theoretical complication of epidural hematoma.
Beneficial effects of TEA require that catheter placement and infusate be targeted at the thoracic segments innervating injured skin, muscle, and bone from which pain input originates. The purpose of this study is to determine the accuracy of thoracic epidural continuous catheter insertion by using fluoroscopic imaging.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Illinois
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Chicago, Illinois, Forenede Stater, 60657
- Advocate Illinois Masonic Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 18- 80 years old patients
- Patients undergoing thoracic surgery
- Patients undergoing upper abdominal surgery
Exclusion Criteria:
- Severe Aortic Valve stenosis
- Active Neurologic Disease
- Allergy to lidocaine or bupivacaine
- Allergy to iodine-based contrast
- Cutaneous Disorders at epidural insertion site
- Preoperative impaired coagulation status
- Pregnancy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Thoracic epidural catheter insertion
Fluoroscopic imaging.
For patients undergoing thoracic epidural analgesia (TEA) with catheter placement for pain associated with thoracic or upper abdominal surgery
|
Contrast media (5 mL) will be injected through the catheter and fluoroscopic images will be obtained and saved in the lateral and antero-posterior projections.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Presumed intervertebral level of epidural catheter
Tidsramme: During procedure
|
At the time of thoracic epidural catheter insertion
|
During procedure
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Radiologic confirmation of epidural catheter placement
Tidsramme: Post procedure within one week.
|
Radiology department will assess within one week after the procedure the images, to confirm the epidural catheter placement.
|
Post procedure within one week.
|
|
Change in Numeric Rating Pain Score from baseline
Tidsramme: 1, 24 and 48 hrs
|
1, 24, and 48 hrs after the end of the surgery.
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1, 24 and 48 hrs
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient satisfaction
Tidsramme: Post procedure at 48 hours
|
Patient satisfaction 48 hrs after the end of surgery
|
Post procedure at 48 hours
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Kenneth D Candido, M.D., Chicago Anesthesia Pain Specialists
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Advocate-IRB-5242
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