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TAP Versus Thoracic Epidural in Major Abdominal Resections

16. april 2018 opdateret af: Spectrum Health Hospitals

Efficacy and Safety of Transversus Abdominis Plane Blocks Versus Thoracic Epidural Anesthesia in Patients Undergoing Major Abdominal Resections: A Prospective, Randomized Controlled Trial

The purpose of this study is to compare two standard methods of pain control management used at Spectrum Health for patients undergoing major surgery. The two methods being compared are the thoracic epidural and the TAP block. The thoracic epidural method involves medication being given through a patient's back and the TAP block involves medication being given through a patient's abdomen (belly). The investigators will compare side effects experienced by the patients that take part in this study, including a change in blood pressure, as well as the patients' opinions about their pain management experience after surgery.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The purpose of this study is to compare the clinical profiles of two currently acceptable analgesia techniques in terms of incidence of hypotension with subsequent fluid administration and pain control by evaluation of both objective and subjective data. The investigators will also compare any additional hospital costs associated with side effect management related to either analgesia method.

This study is a prospective, randomized, open-label trial. Patients who agree to participate and satisfy the inclusion/exclusion criteria will be randomized at the time of enrollment into one of two groups (thoracic epidural or TAP block) using a randomization tool created for the study.

Patients will undergo their scheduled surgery and receive the analgesic method to which they have been randomized. Both methods (thoracic epidural or TAP block) are performed routinely at Spectrum Health and are considered routine care.

Data collected will include medical history and demographics from the patient's medical record. Intraoperative data will include length of surgery, estimated surgical blood loss, complications, blood pressure and medication requirements. Postoperative data will include episodes of hypotension (defined as a systolic BP < 90), fluid requirement in first 24 hours and first 72 hours, pain scores, narcotic usage, return to bowel function (as defined by flatus), time to tolerating a soft or regular diet, and complications. Data will also be collected via a survey each study patient will complete for study purposes only.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

75

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Michigan
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Spectrum Health

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

Beskrivelse

Inclusion Criteria:

  • All patients male or female >18 years old who are scheduled to undergo a major abdominal surgery. Abdominal procedures include, but are not limited to: pancreaticoduodenectomies, distal pancreatectomies, bowel resection, liver resection, esophagectomies, heated intraperitoneal chemotherapy, retroperitoneal excisions and large genitourinary procedures
  • Patients determined by their surgeon as medically able to receive a thoracic epidural or a TAP block interchangeably after consideration of both procedures
  • Patient agrees to participate in this study and provides informed consent

Exclusion criteria:

  • Surgical cases combined with thoracic surgeries
  • Surgical cases where the abdominal operation is performed laparoscopically
  • Patients that have allergies to lidocaine, bupivacaine, levobupivacaine or hydromorphone
  • Patients that are on anticoagulation or antiplatelet medications at time of surgery other than aspirin
  • Surgical cases that typically do not require a regional block in addition to general anesthesia (e.g., cutaneous operations)
  • Adults unable to provide informed consent
  • Children
  • Pregnant women
  • Prisoners
  • Non-English speaking subjects
  • Any other medical condition including mental illness or substance abuse deemed by the investigator to be likely to interfere with a subject's ability to provide informed consent, cooperate and take part in this research study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Transversus Abdominis Plane Block
Transversus Abdominis Plane Block Exparel 1.33% (20ml Volume)
Medicin: Exparel 1.33% (20ml Volume)
Transversus Abdominis Plane Block
Andre navne:
  • TAP Bloker
  • Transversus Abdominis Plane Block
Aktiv komparator: Thoracic Epidural Anesthesia
Thoracic Epidural Anesthesia 0.125% bupivicaine with 2 mcg/ml Fentanyl
Medicin: 0.125% bupivicaine with 2 mcg/ml Fentanyl.
Thoracic Epidural Anesthesia
Andre navne:
  • Epidural
  • Thorax epidural anæstesi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hypotension
Tidsramme: First 24-72 hours postoperatively
The incidence of systolic blood pressure less than 90 mmHg and fluid requirements
First 24-72 hours postoperatively

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient satisfaction relative to pain control and amount of additional narcotic usage
Tidsramme: Post operative day two during hospitalization
A short patient survey during the postoperative period which will collect information on pain management.
Post operative day two during hospitalization

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cost Evaluation
Tidsramme: Postoperative hospitalization an expected average of 6 months
Evaluate costs incurred relative to adverse side effect management and pain management related to either the TAP block or thoracic epidural.
Postoperative hospitalization an expected average of 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Spectrum Health Hospitals

Efterforskere

  • Ledende efterforsker: Mathew Chung, MD, Spectrum Health Hospitals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

3. december 2013

Primær færdiggørelse (Faktiske)

1. august 2016

Studieafslutning (Faktiske)

1. august 2016

Datoer for studieregistrering

Først indsendt

13. maj 2014

Først indsendt, der opfyldte QC-kriterier

22. juli 2014

Først opslået (Skøn)

23. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. april 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. april 2018

Sidst verificeret

1. april 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2013-218

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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