Anxiety and pain are both significant clinical challenges following surgery. Melatonin has been demonstrated to have both anxiolytic and analgesic effects in numerous experimental and clinical studies. This study protocol aims to present the design of a randomized study investigating the anxiolytic and analgesic effects of exogenous melatonin in cosmetic breast augmentation. The study will be a randomized, double-blind, placebo-controlled trial. Included patients are candidates for primary breast augmentation or replacement of existing implants. Patients receive a standardized general anesthetic and postoperative analgesic regimen. The study medication includes 4 separate doses, containing either 10 mg of melatonin or placebo. Doses are administered orally at 21:00 hours of the night before surgery, 120 minutes before surgery, immediately after surgery in the post-anesthesia care unit, and at 21:00 hours of the night following surgery. The two primary outcomes are preoperative anxiety, assessed by the State-Trait Anxiety Inventory and pain, measured by an integrated assessment of longitudinally measured pain intensity and opioid consumption. Secondary outcomes are VAS anxiety, and VAS pain, sleep quality, general fatigue and wellbeing. This study protocol presents in detail the design of a randomized, double-blind, placebo-controlled study investigating the anxiolytic and analgesic effects of repeated doses of exogenous melatonin in patients undergoing cosmetic breast augmentation.
Study protocol and rationale for a prospective, randomized, double-blind, placebo-controlled study to evaluate the effects of Ashwagandha (Withania somnifera) extract on nonrestorative sleep