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

This study is currently recruiting participants.
Verified March 2012 by Hospital for Special Surgery, New York
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01505465
First received: January 4, 2012
Last updated: January 28, 2013
Last verified: March 2012
History of Changes
  Purpose

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 Intervention
Postoperative Pain
Delirium
Confusion
Sleep
 Drug: Melatonin
Drug: Placebo

Study Type: Interventional
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

Resource links provided by NLM:

Drug Information available for: Melatonin
U.S. FDA Resources

Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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


Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505465

Contacts
Contact: Daniel Yoo, MB 646-797-8948 yood@hss.edu
Contact: Ottokar Stundner, MD 646-797-8975 StundnerO@hss.edu

Locations
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Daniel Yoo, MB     646-797-8948     yood@hss.edu    
Contact: Ottokar Stundner, MD     646-797-8975     StundnerO@hss.edu    
Principal Investigator: Stavros Memtsoudis, MD, PhD            
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Stavros G. Memtsoudis, MD, PhD Hospital for Special Surgery, New York
  More Information

Publications:

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01505465     History of Changes
Other Study ID Numbers: 11152
Study First Received: January 4, 2012
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Hospital for Special Surgery, New York:
Total Knee Replacement
Pain
Confusion
Sleep

Additional relevant MeSH terms:
Confusion
Delirium
Pain, Postoperative
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Postoperative Complications
Pathologic Processes
 Pain
Melatonin
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 22, 2013