Postoperative Pain Clinical Trial
— FENTRAOfficial title:
TRANSDERMAL FENTANYL AS A FORM OF REBOUND PAIN REDUCTION IN FAST TRACK PROGRAMME IN PRIMARY KNEE ARTHROPLASTY. Prospective Observational Non-inferiority Study Versus Morphine PCA.
NCT number | NCT06431906 |
Other study ID # | FEN |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2024 |
Est. completion date | March 30, 2026 |
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.
Status | Not yet recruiting |
Enrollment | 106 |
Est. completion date | March 30, 2026 |
Est. primary completion date | March 30, 2026 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - All patients undergoing primary knee arthroplasty ASA I-III between 18 and 80 years of age who have received a transdermal fentanyl patch or morphine PCA as part of their postoperative analgesic strategy Exclusion Criteria: - Prior opioid treatment. - History of previous opioid adverse effects. - History of PONV. - History of medical history that conditions baseline alteration of the data to be collected. - Contraindication to neuroaxial techniques. - Difficulty in understanding the scales used. - Patient's refusal. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Oscar Diaz-Cambronero |
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | - Responders to the decrease in the rate of "rebound pain" with the use of transdermal fentanyl patch relative to morphine PCA: | - Rebound pain score (RPS): Defined as the result of subtracting the minimum score on the pain scale the first 12 hours before the end of action of the peripheral blockade from the maximum score on the pain scale the first 12 hours after the disappearance of the action of the peripheral blockade. To calculate this variable, the numerical pain scale score will be collected 6, 8, 12, 24 and 36 hours after the peripheral nerve block. | 6,8,12,24 and 36hours after the lock | |
Secondary | non-inferiority of PFT vs PCA morphine in terms of early postoperative recovery: | Quality of post-surgical recovery using the QoR 15 scale at 48 hours | 48 hours in the postoperative period | |
Secondary | non-inferiority of PFT vs. morphine PCA in terms of post-surgical analgesia: | Need for prescribed pharmacological rescue at 12 hours: Yes or no
Need for pharmacological rescue at 24 hours: Yes or no Need for pharmacological rescue at 48 hours: Yes or No |
48 hours in the postoperative period | |
Secondary | non-inferiority of PFT vs morphine PCA in terms of adverse effects: | Presence or not of the following adverse effects at 48 hours: pruritus, urinary retention/bladder catheterisation, constipation or abdominal distention, limited mobility, tremor. | 48 hours in the postoperative period |
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