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Saphenous Nerve Block: Single Shot Versus Continuous Infusion to Supplement a Continuous Sciatic Nerve Block After Major Ankle Surgery

18. oktober 2012 opdateret af: University of Aarhus

A Randomized Comparison of Single Injection vs. Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block in Postoperative Pain Treatment After Major Ankle Surgery: Clinical Outcome and Cost Analysis

The most useful method to manage pain after major ankle surgery is infusion of local analgesics with a catheter close to the sciatic nerve.

Sensation from the ankle are carried by three nerves: The tibial and peroneal nerve (unified in the sciatic nerve) and the saphenous nerve.

Study purpose is to test whether continuous infusion of local analgesics by saphenous nerve catheter provide a better treatment of pain in comparison with a single injection nerve block. In addition cost-effectiveness of the two methods are compared.

The 50 patients of the trial are randomized in clusters of ten. We intend to do a preliminary analysis of the data from the first 40 patients. However, it is not an interim analysis. Fifty patients will be included independent of the result of the preliminary analysis. The random allocation of the last 10 patients will also be double-blinded.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Major ankle surgery are known to be very painful the first 48 hours after the operation due to surgical oedema. This pain is difficult to control with systemic analgesics. Pain relief with systemic analgesics requires high doses of intravenous opioids and is associated with breakthrough pain and adverse effects of opioids (sedation, nausea, vomiting, obstipation, urinary retention, respiratory depression).

Continuous, peripheral nerve block with catheter technique for two days minimizes the need for systemic analgesics. Today such a continuous sciatic nerve block is part of the standard pain treatment after major ankle surgery on Aarhus University Hospital. Despite accurate placement of the catheter many patients are in great pain because the saphenous nerve remain unaffected. A single injection block relieve the pain but a block with Ropivacaine only last 8-15 hours.

Severe postoperative pain leads to high opioid dosages, cognitive blurring, nausea, vomiting, reduced ambulation, increased surgical stress response and increased morbidity. Pain problems and adverse effects prolongs postoperative observation time and maybe also time to discharge.

The aim of the study establish whether continuous saphenous nerve block is efficient (pain relief or reduced opioid consumption) and justified (cost-effectiveness analysis) compared with single injection block.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Danmark
      • Aarhus, Danmark, 8000
        • Aarhus University Hospital

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: Elective major ankle surgery

  • total ankle arthroplasty
  • subtalar fusion
  • ankle fusion (non arthroscopic)

Exclusion Criteria:

  • coagulation abnormalities
  • infection in the region of needle insertion
  • systemic infection
  • preoperative consumption of high dose opioid
  • preoperative sciatic or femoral nerve neuropathy
  • preoperative sensory deficit in either of the lower extremities
  • Charcot-Marie-Tooth disorder
  • diabetic neuropathy
  • severe peripheral vascular disease
  • allergy to local anesthetics
  • lack of understanding of Numeric Rank Scale (NRS)
  • communication problems
  • dementia
  • body mass index above 35
  • bilateral continuous sciatic nerve block
  • lack of consent

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 0,2% Ropivacaine

Patients randomized to the experimental group receive a continuous infusion of 0,2 % Ropivacaine by elastomeric infusion pump at 5 ml/h in the saphenous catheter after major ankle surgery. Infusion for 48 postoperative hours.

All patients receive a preoperative single shot of Ropivacaine around saphenous and sciatic nerve and a postoperative continuous sciatic nerve block.
Procedure: Continuous saphenous nerve block
0,2% Ropivacaine by elastomeric infusion pump at 5 ml/h for 48 postoperative hours
Andre navne:
  • Naropin
Placebo komparator: Control

Patients randomized to the control group receive a continuous infusion of isoton saline by elastomeric infusion pump at 5 ml/h in their catheter after major ankle surgery. Infusion for 48 postoperative hours.

All patients receive a preoperative single shot of Ropivacaine around saphenous and sciatic nerve and a postoperative continuous sciatic nerve block.
Procedure: Placebo
Isoton saline by elastomeric infusion pump at 5 ml/h for 48 postoperative hours

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Accumulated opioid consumption
Tidsramme: First 48 hours postoperative
First 48 hours postoperative

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Success rate for saphenous nerve analgesia
Tidsramme: Postoperative, first 48 hours
Pain rated by NRS and opioid consumption
Postoperative, first 48 hours
Success rate for clinical analgesia of foot and ankle
Tidsramme: Postoperative, first 48 hours
Pain rated by NRS and opioid consumption
Postoperative, first 48 hours
Success rate for tibial and peroneal nerve block
Tidsramme: Postoperative, first 48 hours
Pain rated by NRS and test of sensation on the toes
Postoperative, first 48 hours
Localisation of worst pain
Tidsramme: Postoperative, first 48 hours
Postoperative, first 48 hours
Cost-effectiveness
Tidsramme: 2 first postoperative days
2 first postoperative days

Samarbejdspartnere og efterforskere

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

Sponsor

University of Aarhus

Samarbejdspartnere

Aarhus University Hospital

Efterforskere

  • Ledende efterforsker: Thomas F Bendtsen, ph.d., MD, Aarhus University Hospital

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. september 2011

Primær færdiggørelse (Faktiske)

1. oktober 2012

Studieafslutning (Faktiske)

1. oktober 2012

Datoer for studieregistrering

Først indsendt

29. september 2011

Først indsendt, der opfyldte QC-kriterier

30. september 2011

Først opslået (Skøn)

3. oktober 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. oktober 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. oktober 2012

Sidst verificeret

1. oktober 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2011-0184

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 Major Ankle Surgery

Kliniske forsøg med Continuous saphenous nerve block

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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