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Limited analgesic effect of continuous intraarticular ropivacaine for 48h TKA
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ARTHROPLASTY
Limited analgesic effect of continuous intraarticular ropivacaine for 48h TKA .

OrthoEvidence Journal (OE Journal) - ACE Report

OE Journal. 2015;3(18):4 Acta Orthop. 2015 Jun;86(3):373-7
Autori che hanno contribuito

A Ali M Sundberg U Hansson J Malmvik G Flivik

200 patients undergoing total knee arthroplasty (TKA) were randomized to receive either 7.5mg/mL of ropivacaine or 9mg/mL of saline via a continuous intraarticular infusion pump for 48 hours postoperative. The purpose of this study was to determine the effectiveness of a continuous intraarticular infusion of ropivacaine in prolonging the effect of local infiltration analgesia (LIA). With the exception of lower pain in the first postoperative day, results demonstrated no significant differences in postoperative pain, requirement of additional analgesia, or functional recovery between groups.


Dettagli sul finanziamento della pubblicazione +
Finanziamento:
Non-Industry funded
Sponsor:
Region Skane and the Erik and Angelica Sparre Foundation
Conflitti:
None disclosed

Rischio di pregiudizio

8/10

Criteri di segnalazione

20/20

Indice di fragilità

2

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Sì = 1

Incerto = 0,5

Non rilevante = 0

No = 0

La valutazione dei criteri di segnalazione valuta la trasparenza con cui gli autori riportano le caratteristiche metodologiche e sperimentali dello studio all'interno della pubblicazione. La valutazione è suddivisa in cinque categorie che vengono presentate di seguito.

4/4

Randomization

4/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

4/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

L'Indice di Fragilità è uno strumento che aiuta l'interpretazione dei risultati significativi, fornendo una misura della forza di un risultato. L'Indice di Fragilità rappresenta il numero di eventi consecutivi che devono essere aggiunti a un risultato dicotomico per rendere il risultato non più significativo. Un numero piccolo rappresenta un risultato più debole, mentre un numero grande rappresenta un risultato più forte.

Perché questo studio era necessario ora?

Severe pain is often experienced after total knee arthroplasty. Periarticular local infiltration analgesia (LIA) has been introduced in an attempt to improve pain relief, promote early postoperative mobilization and potentially reduce patient length of stay. However, previous studies on its use have provided inconsistent results. Continuous intraarticular analgesia (CIAA) has been suggested as an alternative to prolong the effects of LIA beyond the first 24 postoperative hours. Previous studies have been conducted to measure the efficacy of postoperative CIAA, however the results have been controversial and thus this study was conducted.

Qual era la domanda di ricerca principale?

In patients undergoing total knee arthroplasty, how does continuous intraarticular infusion of ropivacaine compare to saline with regards to analgesia outcomes, assessed over the first 3 months postoperatively?

Caratteristiche dello studio +
Population:
200 patients with primary knee osteoarthritis scheduled to undergo total knee arthroplasty. All patients received intraoperative injection of a solution of ropivacaine, ketorolac, and epinephrine, injected into the posterior and anterior capsules, fascia, the lateral and medial collateral ligaments, and subcutaneously around the joint. All patients underwent the procedure through a standard approach, and with either the Triathlon knee (Stryker, UK) or the PFC knee (DePuy, UK) implanted, depending on the operating surgeon's preference (192 completed follow-up).
Intervention:
Ropivacaine group: Participants received infusion of 7.5mg/mL ropivacaine at 2mL/h for 48h. (n=100; 97 completed; Mean age: 69 +/- 9; 65F/35M)
Comparison:
Control group: Participants received infusion of 9mg/mL NaCl solution at 2mL/h for 48h. (n=100; 95 completed; Mean age: 69 +/- 8; 62F/38M)
Outcomes:
Primary outcome in this study was visual analogue scale (VAS) pain (0-100mm from least to most pain). Other outcomes consisted of active range of motion (ROM) of the knee, straight leg-raising ability, length of hospital stay (LOS), additional analgesics, occasions with nausea and/or vomiting, and number of changes of wound dressings during hospital stay.
Methods:
RCT, double-blind, single-center.
Time:
VAS pain scores were recorded twice a day at 12 noon and 8 p.m. for 3 days. Other outcomes were assessed at postoperative day 3. VAS pain, analgesic consumption, and wound-healing complications were followed-up at 2 weeks and 3 months, and ROM was recorded again at 3 months.
Quali erano i risultati importanti?
  • VAS pain was significantly lower in the ropivacaine group compared to the control group at 12pm (33 +/- 24 vs. 40 +/- 22; p=0.02) and 8pm (36 +/- 24 vs. 43 +/- 21; p=0.03) on the first postoperative day. There were no significant differences between groups in any subsequent follow-up time point (all p>0.05).
  • Significantly more postoperative wound infections were seen in the ropivacaine group compared to the control group (11 vs. 2, respectively; p=0.02)
  • There was no significant difference between groups in additional analgesic consumption (p=0.06).
  • The groups demonstrated similar knee range of motion at both 3 days (p=0.6) and 3 months (p=0.1) postoperatively.
  • There was no significant difference between groups in the percentage of patients who were able to perform the straight leg test on the third postoperative day (ropivacaine group: 93/97; control group: 92/95; p=1.0).
Che cosa devo ricordare di più?

In patients who underwent total knee arthroplasty, those treated with continuous intraarticular analgesia (CIAA) for 48 hours postoperatively demonstrated significantly lower pain than those treated with saline only on the first postoperative day, with differences between groups non-significant thereafter to 3 months. Additionally, no significant difference was noted in requirement of additional analgesia, or parameters of functional recovery. The group treated with CIAA demonstrated a significantly higher incidence of infection compared to the control group.

Come influenzerà l'assistenza ai miei pazienti?

The results of this study suggest that continuous intraarticular infusion of ropivacaine for 48 hours following total knee arthroplasty may have a limited effect on pain outcomes which may not be clinically relevant. Further study is necessary to determine the role of continuous intraarticular analgesia in pain management following total knee arthroplasty.

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Il contenuto di questa pagina è solo a scopo informativo e non intende sostituire la consulenza, la diagnosi o il trattamento medico professionale. Se ha bisogno di cure mediche, si rivolga sempre al suo medico o al pronto soccorso più vicino. Le opinioni, le convinzioni e i punti di vista espressi dalle persone sui contenuti presenti in questa pagina non riflettono le opinioni, le convinzioni e i punti di vista di OrthoEvidence.

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Come citare questo documento ACE Report

OrthoEvidence. Limited analgesic effect of continuous intraarticular ropivacaine for 48h TKA. OE Journal. 2015;3(18):4. Available from: https://myorthoevidence.com/AceReport/Show/limited-analgesic-effect-of-continuous-intraarticular-ropivacaine-for-48h-tka

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