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Comparison Between Epidural and Bilateral Paravertebral Blocks in Liver Resection

2. desember 2014 oppdatert av: University of Pittsburgh

Prospective Randomized Comparative Study Between Epidural and Bilateral Paravertebral Blocks for Perioperative Pain Management in Patients Undergoing Open Liver Resection

This prospective, randomized study is intended to assess the efficacy and safety of bilateral continuous paravertebral blocks compared to continuous epidural block for open liver resection. Hypotheses: Bilateral paravertebral blocks are: 1) equally effective in controlling the perioperative pain; and 2) safe, with less frequent complications following open liver resection when compared to continuous epidural block.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

Background: A number of studies evaluating unilateral continuous paravertebral block demonstrate equal or superior analgesia when compared to epidural analgesia for postoperative pain control (1-7). At the same time, these studies show a decreased incidence of side effects and complications, including: hypotension, pulmonary complications, urinary retention, nausea and vomiting and failed blocks. Several studies also indicate that bilateral paravertebral blocks provide adequate postoperative analgesia (8-14). However, no study has been performed to date that shows a direct comparison between epidural and bilateral paravertebral blocks in patients undergoing open liver resection.Objectives: This prospective, randomized study is intended to assess the efficacy and safety of bilateral continuous paravertebral blocks compared to continuous epidural block for open liver resection. Hypotheses: Bilateral paravertebral blocks are: 1) equally effective in controlling the perioperative pain; and 2) safe, with less frequent complications following open liver resection when compared to continuous epidural block.Methods: A hundred adult patients undergoing elective open liver resection will be randomized to receive a continuous epidural block or continuous bilateral paravertebral blocks for perioperative analgesia. The primary outcome will be the degree of pain control measured by visual analog scale at 24 hours post surgery (at rest and while the patient is performing maximum incentive spirometry). The secondary outcomes will include: 1) Assessment of pain (at rest, with cough, and with ambulation) using the verbal numerical pain scale will be performed postoperatively every 8 hours by floor nursing staff until discharge. During the night the patient will not be awakened for pain assessment. 2) Intravenous opioid requirement: In addition to pain score, postoperative intravenous opioid requirements [hydromorphone (mg)] will also be recorded daily; Frequency of side effects and complications; and other functional status (volume of maximum incentive spirometry, time to extubation, total time for initial ambulation, the length of the hospital stay, time to return of bowel function, readiness for discharge from the hospital, and length of hospital stay). At one month post surgery, health-related quality of life, mortality, and any morbidities will be assessed. Each variable will be compared between the paravertebral group and the epidural group to examine the hypotheses above. Clinical Implications: Bilateral continuous paravertebral blocks could be an equally effective and safe alternative to a continuous epidural block for perioperative pain management in patients who undergo open liver resection.

Studietype

Intervensjonell

Registrering (Faktiske)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • University of Pittsburgh School of Medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • American Society of Anesthesiologists physical status (ASAPS) I to III patients aged over 18 years and scheduled to undergo elective open liver resection at UPMC Presbyterian/Montefiore Hospital will be screened for enrollment in the study. One hundred (100) patients will be enrolled in this study with equal numbers (n = 50) in each arm of the trial. In order to avoid skewed sex difference between the two groups, the sex will be allocated.

Exclusion Criteria:

  • non elective surgery,
  • ASAPS IV or greater,
  • age younger than 18 years,
  • any contraindication to the placement of an epidural catheter or bilateral paravertebral catheters
  • chronic pain conditions
  • preoperative opioid use
  • coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively
  • allergy to any of the drugs/agents used our study protocol
  • preoperative chronic renal dysfunction, who requires renal replacement therapy or serum creatinine greater than 1.4 mg/dL
  • altered mental status (not oriented to place, person, or time),
  • any comorbid conditions that, in the judgment of the consulting surgeon or anesthesiologist, would proscribe the patient from any aspect of the study, -
  • inability to provide adequate informed consent
  • refusal to participate in the study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Bilateral paravertebral blocks
Bilateral continuous paravertebral blocks for open liver resection
use bilateral thoracic paravertebral blocks for pain control
Andre navn:
  • regional anestesi
Ingen inngripen: epidural block
received thoracic epidural block for open liver resection

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain immediately after maximum incentive spirometry
Tidsramme: 24 hours postoperatively
Pain will be assessed using an 11-point verbal numerical pain scale (VAS) with 0 indicating no pain and 10 indicating the worst pain imaginable;(21) pain will be determined 24 hours postoperatively immediately after maximum incentive spirometry.
24 hours postoperatively

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
date of the removal of the catheter
Tidsramme: up to one week after the surgery
date of the removal of the catheter with any requirement of blood transfusion because of coagulation
up to one week after the surgery

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Tetsuro Sakai, MD, PhD, University of Pittsburgh

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2010

Primær fullføring (Faktiske)

1. august 2014

Studiet fullført (Faktiske)

1. november 2014

Datoer for studieregistrering

Først innsendt

17. februar 2011

Først innsendt som oppfylte QC-kriteriene

29. juli 2011

Først lagt ut (Anslag)

2. august 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

3. desember 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. desember 2014

Sist bekreftet

1. desember 2014

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MOD09070393-01 / PRO09070393

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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