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Comparison of Analgesic Methods, and Their Effects on Patient Recovery, Following Liver Surgery (LIVER)

12. marts 2015 opdateret af: Erica Revie, University of Edinburgh

The Effects of Local Infiltration Versus Epidural on Recovery

The provision of adequate pain relief following major liver surgery is essential, not only for patient comfort, but for the prevention of complications, such as chest infection.

Commonly, pain relief in the first few days after surgery is provided by epidural analgesia. Drugs are delivered to the area around the spinal cord, through a fine plastic tube placed in the patients back, and this blocks sensation from the abdomen downwards, thereby providing effective pain relief without the need for opiate analgesia (e.g. morphine). Opiate analgesia can cause nausea, drowsiness and constipation, and its use should be minimised. Epidurals, however, can be associated with some problematic side effects. Low blood pressure is commonly encountered, and not only can its treatment be associated with complications, but patients are often confined to bed.

Mobility can also be limited if muscle function in the legs, (in addition to sensation), is inadvertently affected by the epidural drugs. Other problems associated with epidural use are the relatively common failure of the technique to provide adequate analgesia (20%), and some extremely rare but potentially disastrous complications of epidural insertion.

An alternative technique, is the provision of pain relief directly into the wound, via one or more multi-holed tubes(catheters), placed either in or close to the wound. This technique alone does not provide as effective analgesia as a functioning epidural, but when combined with other intravenous or oral analgesia, has been shown to be effective following a variety of surgical procedures.

It is hypothesised that, following major liver surgery, the use of this latter technique may result in superior outcome and faster recovery, when compared with epidural, by avoidance of the side effects and complications discussed above.

In this study, patients scheduled to undergo major liver surgery at the Royal Infirmary of Edinburgh with be randomly assigned to receive the first two days of pain relief either by epidural, or by wound catheter plus additional analgesia. Both groups will then receive an identical oral analgesic regime for the remainder of the hospital stay.

Outcomes of interest will include the quality of pain relief attained, patient mobility, frequency of complications, and overall recovery time.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

65

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Det Forenede Kongerige
    • Midlothian
      • Edinburgh, Midlothian, Det Forenede Kongerige, EH16 4SA
        • Department of Surgery, Royal Infirmary of Edinburgh

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:

  • Patients undergoing open hepatic resection for benign or malignant conditions.
  • Able to understand the nature of the study and what will be required of them.
  • Men and non-pregnant, non-lactating women.
  • BMI 18-40.

Exclusion Criteria:

  • Patients with contraindication to either epidural or wound catheter techniques.
  • Inability to give written, informed consent.
  • Patients with dementia or neurological impairment.
  • Patients with pre-existing condition limiting mobility.
  • Underlying cirrhotic liver disease.
  • Jaundice (Bilirubin > 50 μmol/L).
  • Liver resection combined with secondary surgical procedure.

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Epidural
Patients will follow a standard optimised recovery protocol, including epidural analgesia for the first 48 hours postoperatively.
Andet: Standard optimised recovery protocol.
  • Epidural analgesia for the first 48 hours postoperatively.
  • Sham wound catheter attached to anterior abdominal wall, for purposes of blinding.
  • Standard oral analgesic regime commenced at 48 hours, and continued until discharge from hospital.
  • Optimised recovery protocol followed throughout.
Eksperimentel: Wound catheter
Patients will follow a standard optimised recovery protocol, but analgesia in the first 48 hours will be delivered through local anaesthetic wound catheters and additional patient-controlled analgesia, instead of epidural analgesia.
Andet: Wound catheter plus patient-controlled analgesia.
  • Continuous infusion of local anaesthetic administered via wound catheters for the first 48 hours postoperatively.
  • Additional patient-controlled intravenous opiate analgesia available to patient during this time period.
  • Sham epidural catheter applied to the patient's back for purposes of blinding.
  • Standard oral analgesic regime commenced at 48 hours, and continued until discharge from hospital.
  • Optimised recovery protocol followed throughout.
Andre navne:
  • ON-Q PainBuster

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Length of time to reach criteria for discharge from hospital.
Tidsramme: This will be assessed twice daily until criteria for dicharge from hospital are met.
This will be assessed twice daily until criteria for dicharge from hospital are met.

Sekundære resultatmål

Resultatmål
Tidsramme
Pain scores, assessed using numerical rating score (0 to 10).
Tidsramme: Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whichever is sooner.
Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whichever is sooner.
Nausea and sedation scores, assessed using numerical rating score (0 to 3).
Tidsramme: Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whicever is sooner.
Assessed at 2, 6 & 12 hours following closure of wound, and daily thereafter until discharge from hospital, or day 7, whicever is sooner.
Sleep disturbance, assessed using numerical rating score (0 to 10).
Tidsramme: Assessed daily from the morning following surgery until discharge from hospital, or day 7, whichever is sooner.
Assessed daily from the morning following surgery until discharge from hospital, or day 7, whichever is sooner.
Volume of intravenous fluids received in the first 48 hours following operation (ml).
Tidsramme: Data collected daily for first 48 hours following operation.
Data collected daily for first 48 hours following operation.
Mobility (percentage of time spent lying / sitting, standing or walking, as measured by ActivPAL meter).
Tidsramme: From the end of the operative procedure until discharge from hospital, or day 7, whichever is sooner.
From the end of the operative procedure until discharge from hospital, or day 7, whichever is sooner.
Time to return of bowel function (days).
Tidsramme: Assessed daily until return of bowel function.
Assessed daily until return of bowel function.
Length of time to meet criteria for discharge from the High Dependency Unit.
Tidsramme: Assessed twice daily until criteria for discharge from the High Dependency Unit met.
Assessed twice daily until criteria for discharge from the High Dependency Unit met.
Complications (General and Technical).
Tidsramme: Assessed daily throughout hospital admission, and at outpatient review clinic 4-6 weeks following discharge from hospital.
Assessed daily throughout hospital admission, and at outpatient review clinic 4-6 weeks following discharge from hospital.

Samarbejdspartnere og efterforskere

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

Sponsor

University of Edinburgh

Samarbejdspartnere

NHS Lothian

Efterforskere

  • Ledende efterforsker: Erica J Revie, University of Edinburgh

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

1. juli 2009

Primær færdiggørelse (Faktiske)

1. juli 2010

Studieafslutning (Faktiske)

1. juli 2010

Datoer for studieregistrering

Først indsendt

4. januar 2010

Først indsendt, der opfyldte QC-kriterier

4. januar 2010

Først opslået (Skøn)

5. januar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. marts 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. marts 2015

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 09/S1102/17
  • 2009/R/SU/04 (Anden identifikator: South East Scotland Research Ethics Committee 02)

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 .

Kliniske forsøg med Postoperativ smerte

Kliniske forsøg med Standard optimised recovery protocol.

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