- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02440542
Popliteal Nerve Block for Postoperative Pain Control in Ankle and Hindfoot Reconstruction
27. november 2018 opdateret af: University of Tennessee
Popliteal Nerve Block for Postoperative Pain Control in Patients Undergoing Ankle and Hindfoot Reconstruction About the Talus
The purpose of this study is to evaluate outcomes of popliteal nerve blocks for postoperative pain control in patients undergoing ankle and hindfoot reconstruction surgeries.
The following outcomes will be analyzed: length of hospital stay, level of pain control, pain medication use, complications, and patient satisfaction.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The study population will be patients undergoing ankle or hindfoot reconstruction about the talus (ankle arthrodesis, subtalar arthrodesis, or ankle arthroplasty) who will be receiving a sciatic nerve block in the popliteal region while in the PACU, following surgery.
Patients will be identified as potential subjects from within the practices of two fellowship-trained foot and ankle orthopaedic surgeons.
Patients will be enrolled in the study by Informed Consent
Beskrivelse
Inclusion Criteria:
- Adult patients ≥ 18 years old
- Patients undergoing ankle, subtalar, pantalar, triple, or tibiotalocalcaneal arthrodesis (CPT codes 27870, 28715, 28725, or 28740)
- Patients undergoing total ankle arthroplasty (CPT code 27702)
- Patients with a preoperative surgical plan to receive a popliteal nerve block during the postoperative period
- Patients whom can be reasonably expected to understand and comply with patient-reported postoperative data collection and surveys
Exclusion Criteria:
- Patients undergoing an ankle or hindfoot reconstruction procedure whom are medically ineligible to receive a safe popliteal nerve block (i.e. patients with neuropathy)
- Patients with documented substance abuse (i.e. history of narcotic abuse could confound pain outcomes)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Postoperative Popliteal nerve block
All patients in the cohort are receiving a postoperative popliteal nerve block as part of their surgical plan.
Outcomes including length of stay, Visual Analog Scale Scores, narcotic intake, and patient satisfaction will be collected as the intervention.
|
Patients will be instructed to complete journals of pain and narcotic use until postoperative day 10.
On first follow-up visit, patients will complete a patient satisfaction survey.
VAS Pain scores and pain medication use will be collected up to 12 weeks postoperatively.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain rating
Tidsramme: Postoperative- through 12 weeks
|
Measured by VAS
|
Postoperative- through 12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Narcotic intake
Tidsramme: Postoperative- through 12 weeks
|
Measured by data from hospital medical record and patient questionnaire
|
Postoperative- through 12 weeks
|
|
Hospital length of stay
Tidsramme: Postoperative- through day of hospital discharge (discharge same day of surgery to approximately 3 days postop)
|
Measured by data from hospital medical record
|
Postoperative- through day of hospital discharge (discharge same day of surgery to approximately 3 days postop)
|
|
Patient satisfaction
Tidsramme: Postoperative- through first surgical follow-up (up to 3 weeks)
|
Measured by patient questionnaire
|
Postoperative- through first surgical follow-up (up to 3 weeks)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2015
Primær færdiggørelse (Faktiske)
1. maj 2018
Studieafslutning (Faktiske)
1. maj 2018
Datoer for studieregistrering
Først indsendt
20. april 2015
Først indsendt, der opfyldte QC-kriterier
6. maj 2015
Først opslået (Skøn)
12. maj 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. november 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. november 2018
Sidst verificeret
1. november 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 15-025
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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