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Peripheral Nerve Block Anaesthesia for Ankle Fracture Surgery - an Exploratory Study: Is Rebound Pain a Problem?

17 april 2015 uppdaterad av: Rune Sort, Herlev Hospital

The purpose of this exploratory study is to characterize the postoperative pain profile of patients undergoing operation with internal fixation of an ankle fracture under nerve block anaesthesia. Special attention is payed towards the possible existence and clinical relevance of a rebound pain phenomenon upon cessation of the nerve block.

Results are used to guide the set up of a randomized controlled trial on the subject.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

Peripheral nerve blocks (PNB) are widely used as anaesthesia and postoperative pain control for surgery. Several studies have suggested multiple benefits of PNB's but primarily shown in elective surgery. Acute conditions like ankle fractures have a different pain profile and risks and benefits of PNB's have not been sufficiently researched in these cases.

A recent study (Goldstein et al. 2012) suggested that a rebound pain effect occur upon cessation of PNB effect defined as a pain increase to a significantly higher level than observed in patients with no PNB at the same point after surgery.

With this prospective, exploratory study we aim to examine the postoperative pain profile after PNB anaesthesia for ankle fracture surgery with focus on plausibility of a rebound pain effect (as defined above) upon PNB cessation.

Secondarily to explore a variety of factors related to postoperative pain profile and feasibility of PNB anaesthesia for ankle surgery including efficacy, risk factors, time factors as well as postoperative recovery and overall patient satisfaction. Results will provide focus for a following randomized controlled trial.

Studietyp

Observationell

Inskrivning (Faktisk)

21

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Danmark
      • Herlev, Danmark, DK-2730
        • Herlev Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

Patients scheduled for internal fixation of an ankle fracture under PNB-anaesthesia at Herlev Hospital identified from the operation booking system via consecutive screening.

Eligible ankle fractures will be those of anatomically uni-, bi- or trimalleolar composition including syndesmotic injury with distal but not proximal fibular fracture. The "third malleolus" is the distal posterior edge of the tibia. Fractures needing external fixation or causing ankle dislocation in need of imminent surgery is not eligible.

Beskrivning

Inclusion Criteria:

  • Patients >= 18 years old scheduled for internal fixation of an ankle fracture as defined above.
  • Ability to read and understand Danish and give informed oral and written consent

Exclusion Criteria:

  • Multitrauma patients / other simultaneous fractures
  • Cognitive or psychiatric dysfunction causing expected inability to comply with study protocol
  • "CAVE" nonsteroidal antiinflammatory drugs (NSAID) or Morphine or Local Anaesthetics as evaluated by anesthesiologist for any reason
  • Primary investigator unavailable for PNB administration at scheduled time of operation
  • Infection at PNB injection site
  • Time from fracture to operation > 5 days
  • Existing neuropathy with functional impairment of the fractured extremity
  • Bodyweight < 50 kg
  • Daily use of opioids > 2 weeks preoperatively
  • Pregnancy
  • Nephropathy requiring dialysis

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Clinically relevant pain increase based on analysis of Numeric Rating Scale pain score (NRS) area under the curve (AUC) for the time period 12-24 hours compared to 0-12 hours postoperatively.
Tidsram: 0, 2, 4, 6, 9, 12, 15, 18, 21 and 24 hours postoperatively
Pain scores are assessed and marked by the patient on a 0-10 numeric rating pain scale (NRS).
0, 2, 4, 6, 9, 12, 15, 18, 21 and 24 hours postoperatively

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Opioid use 12-24 hours compared to 0-12 hours postoperatively
Tidsram: 0-24 hours continuous measurement
Rescue morphine doses are administered intravenously via a patient controlled analgesia (PCA) pump when needed. Times of use are electronically registered.
0-24 hours continuous measurement
Calculated Composite Score for the time intervals 0-24h, 0-12h and 12-24h postoperatively
Tidsram: 0-24 hours postoperatively
We will calculate the "Silverman" composite score of opioid use and pain score combined. This in order to illustrate any increase in pain and to use for sample size calculations for a future randomised study on the subject.
0-24 hours postoperatively
Time to first opioid dose postoperatively
Tidsram: 0-24 hours postoperatively
0-24 hours postoperatively
Time to patient estimated cessation of block effect
Tidsram: 0-24 hours postoperatively
0-24 hours postoperatively
NRS day 1-7 as both "average" and "worst" of the day
Tidsram: Days 1-7 postoperatively
NRS are filled out by the patient in a diary.
Days 1-7 postoperatively
Daily opioid consumption day 1-7
Tidsram: Days 1-7 postoperatively
Registered in a diary.
Days 1-7 postoperatively

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Clinically relevant pain increase based on analysis of Numeric Rating Scale pain score (NRS) area under the curve (AUC) after cessation of nerve block compared to before cessation of nerve block.
Tidsram: 0, 2, 4, 6, 9, 12, 15, 18, 21 and 24 hours postoperatively
The average postoperative time to cessation of nerve block defining the time periods for this comparison will be defined after visual evaluation of the given pain profiles.
0, 2, 4, 6, 9, 12, 15, 18, 21 and 24 hours postoperatively
Score of the Quality of Recovery-15 (QoR-15) questionnaire preoperatively and on postoperative day 1.
Tidsram: Preoperatively and postoperative day 1

Validation of the Danish translation of QoR-15 in this population of patients undergoing acute orthopaedic surgery under PNB-anaesthesia.

A Danish version of the QoR-15 questionnaire is currently being validated in a mixed surgical patient population receiving surgery under general anaesthesia. We will attempt to validate the questionnaire on patients receiving nerve block (PNB) anaesthesia.
Preoperatively and postoperative day 1
QoR-15 questionnaire score on day 1, 2 and 7 postoperatively
Tidsram: Postoperative day 1, 2 and 7.
Postoperative day 1, 2 and 7.
Length of postoperative stay in hospital
Tidsram: Up to 3 weeks
Up to 3 weeks
Time to first meal/appetite postoperatively
Tidsram: 0-24 hours postoperatively
0-24 hours postoperatively
Incidence of postoperative nerve symptoms (PONS) on day 7
Tidsram: Postoperative day 7
Telephone interview
Postoperative day 7
Postoperative nausea and vomiting (PONV) 24 hours postoperatively
Tidsram: 0-24 hours postoperatively
0-24 hours postoperatively
Antiemetic medication 24h postoperatively
Tidsram: 0-24 hours postoperatively
0-24 hours postoperatively
Time used for PNB administration
Tidsram: Preoperatively
Preoperatively
Time to PNB effect on sensory and motor function
Tidsram: Preoperatively
Preoperatively
Length of stay in the Operation Room (OR) - total and pre- and post-operatively
Tidsram: Operation day
Operation day
Duration of surgery
Tidsram: Operation day
Operation day
Partial block rate and Failed block rate
Tidsram: Operation day
Partial = need for supplemental block preoperatively (if PNB seems insufficient after 30 min). Failed = need for General Anaesthesia.
Operation day
Need for PACU admission postoperatively
Tidsram: Operation day
Most patients are expected to be send directly to the Orthopaedic ward following surgery. If not, the reason is noted.
Operation day

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Herlev Hospital

Utredare

  • Huvudutredare: Rune Sort, MD, Department of Anaesthesiology, Herlev Hospital
  • Studierektor: Ann M Møller, Prof., DMSc, Department of Anaesthesiology, Herlev Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2014

Primärt slutförande (Faktisk)

1 december 2014

Avslutad studie (Faktisk)

1 mars 2015

Studieregistreringsdatum

Först inskickad

24 mars 2014

Först inskickad som uppfyllde QC-kriterierna

27 mars 2014

Första postat (Uppskatta)

31 mars 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

20 april 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 april 2015

Senast verifierad

1 april 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • PAnFractRebound-01

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