Clinical Trial: Study of Melatonin on Sleep, Pain, and Confusion After Joint Replacement Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effects of Perioperative Melatonin on Sleep, Pain, and Confusion After Joint Replacement Surgery

Brief Summary: 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

Detailed Summary:
Sponsor: Hospital for Special Surgery, New York

Current Primary Outcome: 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 ]

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.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Perioperative effects of melatonin on post-operative pain scores [ Time Frame: Up to postoperative day 3 ]
    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 ]
    A difference of 25% will be considered clinically important.
  • Melatonin effects on daytime activity [ Time Frame: Up to postoperative day 3 ]
    A 20% difference will be considered clinically important.
  • Melatonin effects on Patient Controlled Analgesia and Postoperative narcotic usage [ Time Frame: Up to 3 days ]
    A 25% in narcotic usage will be considered clinically important


Original Secondary Outcome:

  • Perioperative effects of melatonin on post-operative pain scores [ Time Frame: Up to postoperative day 3 ]
    A difference in 25% in average pain score at each time point be considered clinically significant.
  • Melatonin effects on pain as assessed by patient-controlled anesthesia and postoperative narcotic usage [ Time Frame: Up to postoperative day 3 ]
    A 25% difference in average usage will be considered clinically imporant.
  • Melatonin effects on delirium during post-operative inpatient stay based on clincal assessment in patients 65 and older [ Time Frame: Up to postoperative day 3 ]
    A difference of 25% will be considered clinically important.
  • Melatonin effects on daytime activity [ Time Frame: Up to postoperative day 3 ]
    A 20% difference will be considered clinically important.


Information By: Hospital for Special Surgery, New York

Dates:
Date Received: January 4, 2012
Date Started: February 2012
Date Completion:
Last Updated: December 4, 2013
Last Verified: December 2013