Peripheral Nerve Block Anaesthesia for Ankle Fracture Surgery - an Exploratory Study: Is Rebound Pain a Problem?
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Herlev, Danimarca, DK-2730
- Herlev Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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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.
Lasso di tempo: 0, 2, 4, 6, 9, 12, 15, 18, 21 and 24 hours postoperatively
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Pain scores are assessed and marked by the patient on a 0-10 numeric rating pain scale (NRS).
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0, 2, 4, 6, 9, 12, 15, 18, 21 and 24 hours postoperatively
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Opioid use 12-24 hours compared to 0-12 hours postoperatively
Lasso di tempo: 0-24 hours continuous measurement
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Rescue morphine doses are administered intravenously via a patient controlled analgesia (PCA) pump when needed.
Times of use are electronically registered.
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0-24 hours continuous measurement
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Calculated Composite Score for the time intervals 0-24h, 0-12h and 12-24h postoperatively
Lasso di tempo: 0-24 hours postoperatively
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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.
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0-24 hours postoperatively
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Time to first opioid dose postoperatively
Lasso di tempo: 0-24 hours postoperatively
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0-24 hours postoperatively
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Time to patient estimated cessation of block effect
Lasso di tempo: 0-24 hours postoperatively
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0-24 hours postoperatively
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NRS day 1-7 as both "average" and "worst" of the day
Lasso di tempo: Days 1-7 postoperatively
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NRS are filled out by the patient in a diary.
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Days 1-7 postoperatively
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Daily opioid consumption day 1-7
Lasso di tempo: Days 1-7 postoperatively
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Registered in a diary.
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Days 1-7 postoperatively
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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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.
Lasso di tempo: 0, 2, 4, 6, 9, 12, 15, 18, 21 and 24 hours postoperatively
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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.
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0, 2, 4, 6, 9, 12, 15, 18, 21 and 24 hours postoperatively
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Score of the Quality of Recovery-15 (QoR-15) questionnaire preoperatively and on postoperative day 1.
Lasso di tempo: Preoperatively and postoperative day 1
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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
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QoR-15 questionnaire score on day 1, 2 and 7 postoperatively
Lasso di tempo: Postoperative day 1, 2 and 7.
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Postoperative day 1, 2 and 7.
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Length of postoperative stay in hospital
Lasso di tempo: Up to 3 weeks
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Up to 3 weeks
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Time to first meal/appetite postoperatively
Lasso di tempo: 0-24 hours postoperatively
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0-24 hours postoperatively
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Incidence of postoperative nerve symptoms (PONS) on day 7
Lasso di tempo: Postoperative day 7
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Telephone interview
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Postoperative day 7
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Postoperative nausea and vomiting (PONV) 24 hours postoperatively
Lasso di tempo: 0-24 hours postoperatively
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0-24 hours postoperatively
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Antiemetic medication 24h postoperatively
Lasso di tempo: 0-24 hours postoperatively
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0-24 hours postoperatively
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Time used for PNB administration
Lasso di tempo: Preoperatively
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Preoperatively
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Time to PNB effect on sensory and motor function
Lasso di tempo: Preoperatively
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Preoperatively
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Length of stay in the Operation Room (OR) - total and pre- and post-operatively
Lasso di tempo: Operation day
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Operation day
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Duration of surgery
Lasso di tempo: Operation day
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Operation day
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Partial block rate and Failed block rate
Lasso di tempo: Operation day
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Partial = need for supplemental block preoperatively (if PNB seems insufficient after 30 min).
Failed = need for General Anaesthesia.
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Operation day
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Need for PACU admission postoperatively
Lasso di tempo: Operation day
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Most patients are expected to be send directly to the Orthopaedic ward following surgery.
If not, the reason is noted.
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Operation day
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Rune Sort, MD, Department of Anaesthesiology, Herlev Hospital
- Direttore dello studio: Ann M Møller, Prof., DMSc, Department of Anaesthesiology, Herlev Hospital
Pubblicazioni e link utili
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Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PAnFractRebound-01
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