Efficacy of Melatonin in Improving Sleep Quality Following Primary TKA- a RCT

 The research protocol titled “Efficacy of Melatonin in Improving Sleep Quality Following Primary Total Knee Arthroplasty – A Randomized Controlled Trial” focuses on the often-overlooked issue of postoperative sleep disturbances in patients undergoing total knee arthroplasty (TKA). Sleep disturbances in this population are multifactorial, typically arising from factors such as postoperative pain, opioid consumption, stress, anxiety related to surgery, obstructive sleep apnea, mood disorders, and a history of substance abuse. These disturbances have been shown to correlate with increased postoperative pain and poorer functional outcomes in the early recovery period. Despite their significant impact on patient recovery, there are currently no standardized guidelines addressing sleep disturbances in the postoperative period for orthopaedic patients. This study aims to evaluate whether supplementation with exogenous melatonin can improve sleep quality in patients following primary TKA, utilizing validated instruments such as the Epworth Sleepiness Scale, the Pittsburgh Sleep Quality Index (PSQI), and the PROMIS Sleep Disturbance scores.

The primary objective of this study is to determine whether melatonin supplementation positively influences sleep quality after TKA and whether any observed benefits are limited to the immediate postoperative period or extend up to three months following surgery. The hypothesis underpinning this study is that there is no significant difference in sleep quality between patients receiving melatonin supplementation and those receiving a placebo postoperatively.

The study is designed as a randomized controlled trial involving 200 participants, with 100 patients allocated to the melatonin group and 100 to the placebo group. Patients scheduled to undergo primary TKA at KIMS-Sunshine Hospitals will be enrolled, with those undergoing revision TKA, unicompartmental knee arthroplasty, or having a history of substance abuse or sleep disorders being excluded. Participants in the melatonin group will receive 3mg of melatonin once daily at night for three months postoperatively, whereas the control group will receive a 3 mg placebo on the same schedule. Follow-up assessments will be conducted over a 90-day period to evaluate sleep quality outcomes.

Randomization will be achieved using computer-generated random codes, with allocation concealment maintained throughout the study. The trial employs double-blinded approach, ensuring that surgeons and outcome assessors remain unaware of group allocations to minimize bias. The primary outcome measure will be the change in sleep quality as assessed by the Epworth Sleepiness Scale, PSQI, and PROMIS sleep scores at various postoperative intervals.

Statistical analysis will involve descriptive statistics for baseline characteristics. Categorical variables will be compared using chi-square tests or Fisher’s exact tests where appropriate. Continuous variables will be analyzed using either independent-sample t-tests for normally distributed data or Mann-Whitney U tests for non-parametric data. The study is ethically designed in accordance with the Declaration of Helsinki and has received approval from the Institutional Ethics Committee. Informed consent will be obtained from all participants in their preferred language, including English, Telugu, or Hindi.

The study’s findings are intended for publication and are expected to contribute valuable insights into the management of postoperative sleep disturbances in TKA patients.