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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Herlev, Denemarken, DK-2730
- Herlev Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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.
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Opioid use 12-24 hours compared to 0-12 hours postoperatively
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 0-24 hours postoperatively
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0-24 hours postoperatively
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Time to patient estimated cessation of block effect
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Days 1-7 postoperatively
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Registered in a diary.
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Days 1-7 postoperatively
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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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.
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Up to 3 weeks
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Up to 3 weeks
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Time to first meal/appetite postoperatively
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 0-24 hours postoperatively
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0-24 hours postoperatively
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Antiemetic medication 24h postoperatively
Tijdsspanne: 0-24 hours postoperatively
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0-24 hours postoperatively
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Time used for PNB administration
Tijdsspanne: Preoperatively
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Preoperatively
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Time to PNB effect on sensory and motor function
Tijdsspanne: Preoperatively
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Preoperatively
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Length of stay in the Operation Room (OR) - total and pre- and post-operatively
Tijdsspanne: Operation day
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Operation day
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Duration of surgery
Tijdsspanne: Operation day
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Operation day
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Partial block rate and Failed block rate
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Rune Sort, MD, Department of Anaesthesiology, Herlev Hospital
- Studie directeur: Ann M Møller, Prof., DMSc, Department of Anaesthesiology, Herlev Hospital
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PAnFractRebound-01
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