Study of Melatonin on Sleep, Pain, and Confusion After Joint Replacement Surgery
Condition: Postoperative Pain; Delirium; Confusion; Sleep
MeSH terms: Confusion; Consciousness Disorders
Study type: Interventional

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 description: 
      Sleep disruption is a challenge commonly faced by patients and care providers in the
      perioperative period [1,2] and has been shown to affect postoperative performance after total
      knee arthroplasty [3] . Postoperative sleep disruption is likely influenced by environmental
      factors [4] and anesthetic exposure [5,6] and is known to be exacerbated by postoperative
      pain [7] . In a reciprocal manner, sleep disruption has been shown to exacerbate pain
      perception [8,9] .

      Melatonin is an inexpensive over-the-counter dietary supplement with an established safety
      profile [10] that has shown promise in managing sleep disorders and amelioration of chronic
      and acute pain. Evidence suggests that exogenous melatonin can be efficacious in improving
      sleep disruption in tracheostomized patients in the ICU [11] as well as those experiencing
      jet lag [12,13] .

      Previous studies have found conflicting results regarding the potential for melatonin to
      improve sleep and pain in the perioperative period [14] . These discrepancies may result from
      differences in surgical and anesthetic conditions, differences in melatonin dose and
      administration regimens, variations in study quality, different methods of assessing pain and
      sleep quality, and different patient populations. There is no consensus as to what dose,
      duration, and timing of melatonin administration in the perioperative period are most likely
      to improve sleep quality or quantity. This study was designed to explore the effect of a
      stable regimen of exogenous perioperative melatonin, administered over 6 consecutive nights,
      on postoperative pain, sleep quality, and sleep efficiency in patients undergoing total knee
      arthroplasty under regional anesthesia with sedation. To our knowledge, this study is the
      first to examine perioperative subjected sleep quality as well as sleep time and efficiency
      as measured by the validated objective tool of wrist actigraphy in this population.

      This study examined the hypotheses that sleep disruption occurs in the context of total knee
      arthroplasty performed under regional anesthesia with sedation and that perioperative
      melatonin can modulate pain and sleep disruption after total knee arthroplasty.

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       14. Andersen L.P., Rosenberg J., Gogenur I.: Perioperative melatonin: not ready for prime
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Intervention name(s): Melatonin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.; 5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Total Knee Replacement; Pain; Confusion; Sleep