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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01505465
Recruitment Status : Completed
First Posted : January 6, 2012
Results First Posted : August 31, 2017
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Description
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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

Condition or disease Intervention/treatment Phase
Postoperative Pain Delirium Confusion Sleep Drug: Melatonin Drug: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Perioperative Melatonin on Sleep, Pain, and Confusion After Joint Replacement Surgery
Study Start Date : February 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Study: Melatonin Drug: 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 Drug: Placebo
5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505465


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: Stavros G. Memtsoudis, MD, PhD Hospital for Special Surgery, New York
More Information
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Publications:

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01505465    
Other Study ID Numbers: 11152
First Posted: January 6, 2012    Key Record Dates
Results First Posted: August 31, 2017
Last Update Posted: August 31, 2017
Last Verified: March 2017
Keywords provided by Hospital for Special Surgery, New York:
Total Knee Replacement
Pain
Confusion
Sleep
Additional relevant MeSH terms:
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Delirium
Confusion
Consciousness Disorders
Neurologic Manifestations
Neurobehavioral Manifestations
Nervous System Diseases
Neurocognitive Disorders
 Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants