Evidence map›Paper›PMID 21425510›Full record

Trial reportRegional anesthesia and pain medicine

Long-term pain, stiffness, and functional disability after total knee arthroplasty with and without an extended ambulatory continuous femoral nerve block: a prospective, 1-year follow-up of a multicenter, randomized, triple-masked, placebo-controlled trial.

Brian M Ilfeld, Jonathan J Shuster, Douglas W Theriaque, Edward R Mariano, Paul J Girard, Vanessa J Loland, Scott Meyer, John F Donovan, George A Pugh, Linda T Le and 2 more

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Regional anesthesia and pain medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Observational
  8. Postoperative Regional Analgesia Is Effective in Preserving Perforin-Expressing Lymphocytes in Patients After Total Knee Replacement.Medical science monitor : international medical journal of experimental and clinical research · 2018
    Article
  9. Patients' expectations about total knee arthroplasty outcomes.Health expectations : an international journal of public participation in health care and health policy · 2016
    Article
  10. Pain after knee arthroplasty: an unresolved issue.Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA · 2014
    Review
  11. Article
  12. Neurophysiology of pain and hypnosis for chronic pain.Translational behavioral medicine · 2012
    Article
  13. The role of continuous peripheral nerve blocks.Anesthesiology research and practice · 2012
    Article
  14. Article
  15. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Brian M IlfeldDepartment of Anesthesiology, University of California San Diego, San Diego, CA 92103-8770, USA. bilfeld@ucsd.edu
Jonathan J Shuster
Douglas W Theriaque
Edward R Mariano
Paul J Girard
Vanessa J Loland
Scott Meyer
John F Donovan
George A Pugh
Linda T Le
Daniel I Sessler
Scott T Ball

Funding

ZOVIRAX CREAM TO TREAT HERPES LABIALIS IN ADOLESCENTSM01RR000827 · NCRR · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI HAAS, RICHARD H · 1985 to 2010
$74.3M
WHITE MATTER AND COGNITION IN PARKINSON'S DISEASEM01RR000082 · NCRR · UNIVERSITY OF FLORIDA · PI BYRNE, BARRY J · 1985 to 2009
$29.7M
UF Clinical and Translational Science AwardUL1TR000064 · NCATS · UNIVERSITY OF FLORIDA · PI NELSON, DAVID R · 2012 to 2014
$12.2M
Perineural Anesthetic Infusion After Joint ReplacementK23GM077026 · NIGMS · UNIVERSITY OF FLORIDA · PI ILFELD, BRIAN M · 2005 to 2009
$617k
NCATS NIH HHS UL1 TR000064NCRR NIH HHS M01 RR000082NCRR NIH HHS M01 RR000827NCRR NIH HHS RR00082NCRR NIH HHS RR000827NCRR NIH HHS RR025208NIGMS NIH HHS GM077026NIGMS NIH HHS K23 GM077026
6 · The paper itself

Abstract

backgroundPreviously, we have demonstrated that extending a continuous femoral nerve block (cFNB) from overnight to 4 days after total knee arthroplasty (TKA) provides clear benefits during the infusion, but not subsequent to catheter removal. However, there were major limitations in generalizing the results of that investigation, and we subsequently performed a very similar study using a multicenter format, with many health care providers, in patients on general orthopedic wards, thus greatly improving inference of the results to the general population. Not surprisingly, the perioperative/short-term outcomes differed greatly from the first, more limited study. We now present a prospective follow-up study of the previously published, multicenter, randomized controlled clinical trial to investigate the possibility that an extended ambulatory cFNB decreases long-term pain, stiffness, and functional disability after TKA, which greatly improves inference of the results to the general population.

methodsSubjects undergoing TKA received a cFNB with ropivacaine 0.2% from surgery until the following morning, at which time patients were randomized to continue either perineural ropivacaine (n=28) or normal saline (n=26). Patients were discharged with their catheter and a portable infusion pump, and catheters were removed on postoperative day 4. Health-related quality of life was measured using the Western Ontario and McMaster Universities Osteoarthritis Index preoperatively and then at 7 days, as well as 1, 2, 3, 6, and 12 months after surgery. This index evaluates pain, stiffness, and physical functional disability. For inclusion in the analysis, we required a minimum of 4 of the 6 time points, including day 7 and at least 2 of months 3, 6, and 12.

resultsThe 2 treatment groups had similar Western Ontario and McMaster Universities Osteoarthritis scores for the mean area-under-the-curve calculations (point estimate for the difference in mean area under the curve for the 2 groups [overnight infusion group - extended infusion group]=3.8; 95% confidence interval, -3.8 to +11.3; P=0.32) and at all individual time points (P>0.05).

conclusionsThis investigation found no evidence that extending an overnight cFNB to 4 days improves (or worsens) subsequent pain, stiffness, or physical function after TKA in patients of multiple centers convalescing on general orthopedic wards.

Indexed as

Femoral NerveNerve BlockAdolescentAdultAgedAmbulatory CareArthroplasty, Replacement, KneeFemaleFollow-Up StudiesHumansMaleMiddle AgedPostoperative PainProspective StudiesRecovery of FunctionTime Factors

Identifiers

PMID21425510
PMCPMC3073537

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.