Study of Melatonin on Sleep, Pain, and Confusion After Joint Replacement Surgery
Pain, confusion, and breaks in normal sleep cycles have been challenges commonly faced by patients after undergoing joint surgeries. To address these issues, melatonin, an inexpensive over-the-counter supplement, has shown in previous to help manage sleep disorders, prevent and treat post-operative confusion in patients over 70 years of age, and reduce pain. The purpose of this study is to establish whether melatonin can aid in reducing pain and post-operative confusion and improve sleep quality after total knee replacement
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Effects of Perioperative Melatonin on Sleep, Pain, and Confusion After Joint Replacement Surgery|
- To see if melatonin or placebo creates differences in total sleep time, sleep efficiency, and nighttime awakening for patients undergoing total knee replacements [ Time Frame: Up to postoperative day 3 ] [ Designated as safety issue: No ]
Primary outcome will be measured by an Actigraph watch, a light-weight bracelet worn on the non-dominant wrist. The device uses triaxial accelerometers and proprietary algorithms to measure parameters of sleep and activity.
A 15%, 15%, and 25% difference from baseline readings in total sleep time, sleep efficiency, and nighttime awakening will be considered clinically important respectively.
- Perioperative effects of melatonin on post-operative pain scores [ Time Frame: Up to postoperative day 3 ] [ Designated as safety issue: No ]A difference in 25% in average pain score at each time point be considered clinically significant.
- Melatonin effects on delirium during post-operative inpatient stay based on clinical assessment in patients 65 and older [ Time Frame: Up to postoperative day 3 ] [ Designated as safety issue: No ]A difference of 25% will be considered clinically important.
- Melatonin effects on daytime activity [ Time Frame: Up to postoperative day 3 ] [ Designated as safety issue: No ]A 20% difference will be considered clinically important.
- Melatonin effects on Patient Controlled Analgesia and Postoperative narcotic usage [ Time Frame: Up to 3 days ] [ Designated as safety issue: No ]A 25% in narcotic usage will be considered clinically important
|Study Start Date:||February 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
|Experimental: Study: Melatonin||
5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
|Placebo Comparator: Control: Placebo||
5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505465
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Stavros G. Memtsoudis, MD, PhD||Hospital for Special Surgery, New York|