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No Effect of Oral Mecobalamin on Skin Numbness at 3 Months After Total Knee Arthroplasty: A Randomized, Double-Blinded, Placebo-Controlled Superiority Trial

An area of skin numbness (AON) around an incision commonly occurs following total knee arthroplasty (TKA). Mecobalamin has been shown to facilitate peripheral nerve recovery in various conditions; accordingly, the present study aimed to investigate the ameliorative effect of mecobalamin on AON follo...

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Autores principales: Ruangsomboon, Pakpoom, Nepal, Sarthak, Udomkiat, Pacharapol, Unnanuntana, Aasis
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Journal of Bone and Joint Surgery, Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9000051/
https://www.ncbi.nlm.nih.gov/pubmed/35425873
http://dx.doi.org/10.2106/JBJS.OA.22.00002
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author Ruangsomboon, Pakpoom
Nepal, Sarthak
Udomkiat, Pacharapol
Unnanuntana, Aasis
author_facet Ruangsomboon, Pakpoom
Nepal, Sarthak
Udomkiat, Pacharapol
Unnanuntana, Aasis
author_sort Ruangsomboon, Pakpoom
collection PubMed
description An area of skin numbness (AON) around an incision commonly occurs following total knee arthroplasty (TKA). Mecobalamin has been shown to facilitate peripheral nerve recovery in various conditions; accordingly, the present study aimed to investigate the ameliorative effect of mecobalamin on AON following TKA, as compared with a placebo. METHODS: This superiority study was a double-blinded, randomized controlled trial. All patients undergoing primary TKA were assessed for eligibility. Included patients were randomized to receive either mecobalamin (500 µg, twice daily) or placebo (corn starch powder; 500 µg, twice daily) for 3 months. The primary outcome was the change in the AON around the surgical site from 2 weeks to 3 months after TKA. Secondary outcomes included the rates of different adverse events, functional outcomes, and visual analogue scale patient satisfaction scores. RESULTS: A total of 154 patients were enrolled, with 77 patients each in the mecobalamin and placebo groups. The mean AON among patients in the mecobalamin group was 61.6 cm(2) at baseline (2 weeks) and 29.1 cm(2) at 3 months, compared with 55.9 cm(2) and 33.2 cm(2) among patients in the placebo group, respectively. Intention-to-treat analysis showed no significant difference in the change in AON around the surgical site between the 2 groups (mean difference, 7.5; 95% confidence interval, −4.2 to 25.3; p = 0.159). The rates of adverse events, functional outcomes, and visual analogue scale patient satisfaction score were also not significantly different between groups. CONCLUSIONS: Mecobalamin did not demonstrate superiority over a placebo in reducing the AON around the surgical site at 3 months after primary TKA. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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spelling pubmed-90000512022-04-13 No Effect of Oral Mecobalamin on Skin Numbness at 3 Months After Total Knee Arthroplasty: A Randomized, Double-Blinded, Placebo-Controlled Superiority Trial Ruangsomboon, Pakpoom Nepal, Sarthak Udomkiat, Pacharapol Unnanuntana, Aasis JB JS Open Access Scientific Articles An area of skin numbness (AON) around an incision commonly occurs following total knee arthroplasty (TKA). Mecobalamin has been shown to facilitate peripheral nerve recovery in various conditions; accordingly, the present study aimed to investigate the ameliorative effect of mecobalamin on AON following TKA, as compared with a placebo. METHODS: This superiority study was a double-blinded, randomized controlled trial. All patients undergoing primary TKA were assessed for eligibility. Included patients were randomized to receive either mecobalamin (500 µg, twice daily) or placebo (corn starch powder; 500 µg, twice daily) for 3 months. The primary outcome was the change in the AON around the surgical site from 2 weeks to 3 months after TKA. Secondary outcomes included the rates of different adverse events, functional outcomes, and visual analogue scale patient satisfaction scores. RESULTS: A total of 154 patients were enrolled, with 77 patients each in the mecobalamin and placebo groups. The mean AON among patients in the mecobalamin group was 61.6 cm(2) at baseline (2 weeks) and 29.1 cm(2) at 3 months, compared with 55.9 cm(2) and 33.2 cm(2) among patients in the placebo group, respectively. Intention-to-treat analysis showed no significant difference in the change in AON around the surgical site between the 2 groups (mean difference, 7.5; 95% confidence interval, −4.2 to 25.3; p = 0.159). The rates of adverse events, functional outcomes, and visual analogue scale patient satisfaction score were also not significantly different between groups. CONCLUSIONS: Mecobalamin did not demonstrate superiority over a placebo in reducing the AON around the surgical site at 3 months after primary TKA. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. Journal of Bone and Joint Surgery, Inc. 2022-04-08 /pmc/articles/PMC9000051/ /pubmed/35425873 http://dx.doi.org/10.2106/JBJS.OA.22.00002 Text en Copyright © 2022 The Authors. Published by The Journal of Bone and Joint Surgery, Incorporated. All rights reserved. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (https://creativecommons.org/licenses/by-nc-nd/4.0/) (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.
spellingShingle Scientific Articles
Ruangsomboon, Pakpoom
Nepal, Sarthak
Udomkiat, Pacharapol
Unnanuntana, Aasis
No Effect of Oral Mecobalamin on Skin Numbness at 3 Months After Total Knee Arthroplasty: A Randomized, Double-Blinded, Placebo-Controlled Superiority Trial
title No Effect of Oral Mecobalamin on Skin Numbness at 3 Months After Total Knee Arthroplasty: A Randomized, Double-Blinded, Placebo-Controlled Superiority Trial
title_full No Effect of Oral Mecobalamin on Skin Numbness at 3 Months After Total Knee Arthroplasty: A Randomized, Double-Blinded, Placebo-Controlled Superiority Trial
title_fullStr No Effect of Oral Mecobalamin on Skin Numbness at 3 Months After Total Knee Arthroplasty: A Randomized, Double-Blinded, Placebo-Controlled Superiority Trial
title_full_unstemmed No Effect of Oral Mecobalamin on Skin Numbness at 3 Months After Total Knee Arthroplasty: A Randomized, Double-Blinded, Placebo-Controlled Superiority Trial
title_short No Effect of Oral Mecobalamin on Skin Numbness at 3 Months After Total Knee Arthroplasty: A Randomized, Double-Blinded, Placebo-Controlled Superiority Trial
title_sort no effect of oral mecobalamin on skin numbness at 3 months after total knee arthroplasty: a randomized, double-blinded, placebo-controlled superiority trial
topic Scientific Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9000051/
https://www.ncbi.nlm.nih.gov/pubmed/35425873
http://dx.doi.org/10.2106/JBJS.OA.22.00002
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