Does Melatonin Improve Sleep Following Primary Total Hip Arthroplasty? A Randomized, Double-Blind, Placebo-Controlled Trial
Abstract
BACKGROUND
Sleep impairment following total hip arthroplasty (THA) is common and may decrease patient satisfaction and early recovery. Standardized postoperative recommendations for sleep disturbance have not been established. We aimed to assess whether melatonin use improves sleep quality and quantity in the acute period following THA.
METHODS
Patients undergoing primary, elective THA between July 2021 and March 2024 were prospectively enrolled and randomized to receive either five mg of melatonin or a placebo nightly for 14 days postoperatively. Participants recorded nightly pain scores on the visual analog scale (VAS), the number of hours slept, and the number of nighttime awakenings in a sleep diary. Sleep disturbance was assessed preoperatively and on postoperative day (POD) 14 using the patient-reported outcome measurement information system sleep disturbance (PROMIS-SD) form. Epworth Sleepiness Scores (ESS) were collected to assess sleep quality and were the primary outcome of this study. Of the 139 patients who completed the study protocol, there were 64 patients in the placebo group and 75 patients in the melatonin group.
RESULTS
Both groups demonstrated comparable postoperative ESS (melatonin: 6.0 ± 4.0; placebo: 6.8 ± 4.5, P = 0.35). Melatonin patients experienced significantly more hours slept on POD2 (6.5 ± 1.7; 5.7 ± 2.4, P = 0.017) and averaged over POD one to three (6.1 ± 1.6; 5.7 ± 2.0, P = 0.14), although this was not statistically significant. Fewer…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 139 participants or records.
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