Postoperative Pain Clinical Trial
Official title:
Effects of Perioperative Melatonin on Sleep, Pain, and Confusion After Joint Replacement Surgery
NCT number | NCT01505465 |
Other study ID # | 2012-032 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2012 |
Est. completion date | June 2013 |
Verified date | April 2022 |
Source | Hospital for Special Surgery, New York |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 50 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Hospital for Special Surgery | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Hospital for Special Surgery, New York |
United States,
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Gitto E, Reiter RJ, Cordaro SP, La Rosa M, Chiurazzi P, Trimarchi G, Gitto P, Calabrò MP, Barberi I. Oxidative and inflammatory parameters in respiratory distress syndrome of preterm newborns: beneficial effects of melatonin. Am J Perinatol. 2004 May;21(4):209-16. — View Citation
Gitto E, Romeo C, Reiter RJ, Impellizzeri P, Pesce S, Basile M, Antonuccio P, Trimarchi G, Gentile C, Barberi I, Zuccarello B. Melatonin reduces oxidative stress in surgical neonates. J Pediatr Surg. 2004 Feb;39(2):184-9; discussion 184-9. — View Citation
Kärkelä J, Vakkuri O, Kaukinen S, Huang WQ, Pasanen M. The influence of anaesthesia and surgery on the circadian rhythm of melatonin. Acta Anaesthesiol Scand. 2002 Jan;46(1):30-6. — View Citation
Kücükakin B, Klein M, Lykkesfeldt J, Reiter RJ, Rosenberg J, Gögenur I. No effect of melatonin on oxidative stress after laparoscopic cholecystectomy: a randomized placebo-controlled trial. Acta Anaesthesiol Scand. 2010 Oct;54(9):1121-7. doi: 10.1111/j.1399-6576.2010.02294.x. — View Citation
Kücükakin B, Wilhelmsen M, Lykkesfeldt J, Reiter RJ, Rosenberg J, Gögenur I. No effect of melatonin to modify surgical-stress response after major vascular surgery: a randomised placebo-controlled trial. Eur J Vasc Endovasc Surg. 2010 Oct;40(4):461-7. doi: 10.1016/j.ejvs.2010.06.014. Epub 2010 Jul 17. — View Citation
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Shigeta H, Yasui A, Nimura Y, Machida N, Kageyama M, Miura M, Menjo M, Ikeda K. Postoperative delirium and melatonin levels in elderly patients. Am J Surg. 2001 Nov;182(5):449-54. — View Citation
Sultan SS. Assessment of role of perioperative melatonin in prevention and treatment of postoperative delirium after hip arthroplasty under spinal anesthesia in the elderly. Saudi J Anaesth. 2010 Sep;4(3):169-73. doi: 10.4103/1658-354X.71132. — View Citation
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perioperative Sleep Efficiency | Sleep time change from 96 hours before surgery to 72 hours after surgery | 96 hours before surgery to 72 hours after surgery | |
Secondary | Perioperative Effects of Melatonin on Post-operative Pain Scores | A difference in 25% in average pain score at each time point be considered clinically significant. | Up to postoperative day 3 | |
Secondary | Melatonin Effects on Delirium During Post-operative Inpatient Stay Based on Clinical Assessment in Patients 65 and Older | A difference of 25% will be considered clinically important. | Up to postoperative day 3 | |
Secondary | Melatonin Effects on Daytime Activity | A 20% difference will be considered clinically important. | Up to postoperative day 3 | |
Secondary | Melatonin Effects on Patient Controlled Analgesia and Postoperative Narcotic Usage | A 25% in narcotic usage will be considered clinically important | Up to 3 days |
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