Efficacy and safety of pre-emptive tapentadol on pain control in total knee arthroplasty: A randomized, double-blind, placebo-controlled trial
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: BACKGROUND Although opioids and non-steroidal anti-inflammatory drugs are commonly used as preemptive analgesics in total knee arthroplasty (TKA), their side effects are a major concern. Tapentadol, a synthetic opioid analgesic, is noted for its higher potency, lower abuse potential, and better gastrointestinal tolerability compared to traditional opioids. However, its efficacy and safety as preemptive analgesia in TKA have not been evaluated. AIM To hypothesize that preemptive use of tapentadol significantly reduces postoperative pain and rescue analgesic consumption in TKA patients. Clinically, this may reduce opioid burden and improve recovery protocols. METHODS Ninety patients undergoing unilateral TKA were randomized to receive either tapentadol (single dose of 100 mg sustained-release, n = 45) or a matched placebo 1 hour before surgery. Postoperative pain was assessed using the visual analog scale (VAS), and total pain reduction scores were recorded. Total rescue analgesic consumption and side effects were monitored for 24 hours. Blood samples were collected 6 hours postoperatively to measure plasma levels of cholecystokinin (CCK) (a potential biomarker of pain) and tapentadol using enzyme-linked immunosorbent assay and high-performance liquid chromatography, respectively. RESULTS The baseline characteristics of both groups were comparable. The 24-hour VAS scores, the primary outcome, were significantly lower in the tapentadol group median [interquartile range (IQR)] [1.0 (1.0-3.0)] compared to the placebo group [3.5 (2.0-5.0)]. Significant differences in VAS scores were observed at 4 hours, 6 hours, and 12 hours postoperatively (P < 0.05). Requests for rescue analgesia were significantly delayed in the tapentadol group (P = 0.01), and the total dose of analgesics used was significantly lower [median (IQR): 3 (2-4)] compared to the placebo group [4.5 (3-5), P = 0.001]. No major adverse events were observed in either group. Plasma tapentadol concentrations correlated well with pain intensity, whereas no correlation was found between CCK levels and pain intensity. CONCLUSION A preemptive single dose of 100 mg oral tapentadol is safe, effective, and significantly reduces postoperative pain and rescue analgesic requirements in TKA patients. This approach may reduce opioid dependence and support enhanced recovery protocols.
Source: World Journal of Orthopedics
Institution: All India Institute of Medical Sciences Bhubaneswar
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4415222389