Bhattacharjee S, Srinivasan A, Tripathy SK, Doki SK, Hota D. Efficacy and safety of pre-emptive tapentadol on pain control in total knee arthroplasty: A randomized, double-blind, placebo-controlled trial. World J Orthop 2025; 16(10): 110233 [DOI: 10.5312/wjo.v16.i10.110233]
Corresponding Author of This Article
Sujit Kumar Tripathy, Professor, Department of Orthopedics, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar 751019, Odisha, India. ortho_sujit@aiimsbhubaneswar.edu.in
Research Domain of This Article
Orthopedics
Article-Type of This Article
Randomized Controlled Trial
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Oct 18, 2025 (publication date) through Oct 25, 2025
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Journal Information of This Article
Publication Name
World Journal of Orthopedics
ISSN
2218-5836
Publisher of This Article
Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA
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Bhattacharjee S, Srinivasan A, Tripathy SK, Doki SK, Hota D. Efficacy and safety of pre-emptive tapentadol on pain control in total knee arthroplasty: A randomized, double-blind, placebo-controlled trial. World J Orthop 2025; 16(10): 110233 [DOI: 10.5312/wjo.v16.i10.110233]
Samiksha Bhattacharjee, Anand Srinivasan, Debasish Hota, Department of Pharmacology, All India Institute of Medical Sciences, Bhubaneshwar 751019, Odisha, India
Sujit Kumar Tripathy, Sunil Kumar Doki, Department of Orthopedics, All India Institute of Medical Sciences, Bhubaneswar 751019, Odisha, India
Author contributions: Bhattacharjee S prepared the initial draft of the manuscript; Bhattacharjee S and Srinivasan A did the statistical analysis; Bhattacharjee S, Tripathy SK, and Doki SK conducted the trial; Srinivasan A, Tripathy SK, and Hota D provided intellectual inputs; Bhattacharjee S and Doki SK collected the data; Srinivasan A and Hota D designed the study; all authors read the manuscript and approved the manuscript for publication.
Institutional review board statement: The study has been approved by the Institutional Ethics Committee (No. T/IM-NF/Pharma/02/17).
Clinical trial registration statement: The trial is registered at clinicaltrials.gov (No. NCT03351517).
Informed consent statement: Informed consent was obtained from all participants before recruitment into the study.
Conflict-of-interest statement: No conflict of interest to disclose.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: Data will be shared on request and institutional permission.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Sujit Kumar Tripathy, Professor, Department of Orthopedics, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar 751019, Odisha, India. ortho_sujit@aiimsbhubaneswar.edu.in
Received: June 3, 2025 Revised: June 27, 2025 Accepted: September 19, 2025 Published online: October 18, 2025 Processing time: 136 Days and 22 Hours
Core Tip
Core Tip: This randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of a single preemptive 100 mg dose of sustained-release tapentadol in patients undergoing total knee arthroplasty (TKA). Tapentadol significantly reduced postoperative pain scores, delayed the need for rescue analgesia, and lowered total analgesic consumption without increasing opioid-related side effects. Its plasma concentration correlated strongly with pain intensity, while cholecystokinin levels did not. With a favorable safety profile and analgesic efficacy, tapentadol may be a valuable component of multimodal analgesia in TKA, offering an opioid-sparing strategy with reduced gastrointestinal and central nervous system side effects. Further multicenter validation is warranted.
