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Transdermal Fentanyl as a Form of Rebound Pain Reduction in Fast Track Programme in Primary Knee Arthroplasty.

NCT06431906 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 106

Last updated 2024-05-29

No results posted yet for this study

Summary

Total knee arthroplasty is a common surgery in routine clinical practice that, although it achieves an improvement in the functionality and quality of life of patients, it causes intense postoperative pain. In this regard, locoregional block techniques are commonly used for the immediate postoperative period. However, these techniques have the disadvantage of being of limited duration and the appearance of so-called "rebound pain" when their effect wears off. To counteract this problem and maintain adequate analgesic control over a longer period of time, the use of a transdermal fentanyl patch seems to be a good option, with advantages over the traditional approach of placing a morphine PCA.

Specifically, the aims of the study are: the evaluation of the decrease in the rate of rebound pain after locoregional techniques using a transdermal fentanyl patch after primary knee arthroplasty, as well as the evaluation of non-inferiority in terms of functional recovery, analgesic efficacy and adverse effects compared to morphine PCA.

Methods: This will be a prospective observational cohort study, with a total N of 106 patients undergoing total knee arthroplasty who meet the study inclusion criteria. The numerical pain rating scale score will be collected at 6,8,12,24 and 26h from which the "rebound pain score" will be calculated. The need for pharmacological rescue will be assessed as well as the appearance of adverse effects at 12, 24 and 36h and finally the QoR15 scale will be assessed at 36h.

Conditions

  • Postoperative Pain

Sponsors & Collaborators

  • Oscar Diaz-Cambronero

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2026-03-30
Completion
2026-03-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06431906 on ClinicalTrials.gov