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Completed

NCT Number: NCT01505465

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

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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  • Kain Z.N., Caldwell-Andrews A.A.: Sleeping characteristics of adults undergoing outpatient elective surgery: a cohort study. J Clin Anesth 2003; 15: pp. 505.
  • Cremeans-Smith J.K., Millington K., Sledjeski E., et. al.: Sleep disruptions mediate the relationship between early postoperative pain and later functioning following total knee replacement surgery. J Behav Med 2006; 29: pp. 215.
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  • Dietary supplements: a framework for evaluating safety.2005.The National Academies Press Washington, DC
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  • Suhner A., Schlagenhauf P., Hofer I., et. al.: Effectiveness and tolerability of melatonin and zolpidem for the alleviation of jet lag. Aviat Space Environ Med 2001; 72: pp. 638.
  • Suhner A., Schlagenhauf P., Johnson R., et. al.: Comparative study to determine the optimal melatonin dosage form for the alleviation of jet lag. Chronobiol Int 1998; 15: pp. 655.
  • Andersen L.P., Rosenberg J., Gogenur I.: Perioperative melatonin: not ready for prime time. Br J Anaesth 2014; 112: pp. 7.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18-90 years old undergoing elective, primary total knee replacement
  • American Society of Anesthesiologists (ASA) Physical Status I-III
  • Epidural anesthesia/Patient Controlled Analgesia candidate

Exclusion criteria

  • Mental impairment
  • Pre-operative use of benzodiazepines, narcotics, or prescription/over-the counter (OTC) sleep aids
  • Pre-operative use of calcium channel blockers
  • Insomnia
  • Recent drug or alcohol abuse
  • Psychiatric disorders other than anxiety, including depression
  • Diabetes

Treatment and study plan

Melatonin

Drug

5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.

Placebo

Drug

5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery

Primary outcomes

  1. Perioperative Sleep Efficiency

    Time frame: 96 hours before surgery to 72 hours after surgery

    Sleep time change from 96 hours before surgery to 72 hours after surgery

Secondary outcomes

  1. 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.

  2. 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.

  3. Melatonin Effects on Daytime Activity

    Time frame: Up to postoperative day 3

    A 20% difference will be considered clinically important.

  4. 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

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 6, 2012
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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