TKA Melatonin and Sleep Quality

Sleep Initiation and Maintenance Disorders Clinical Trial

Official title:

Association Between Melatonin Use and Improved Sleep Quality After Total Knee Arthroplasty: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05332717
• Other study ID #: 2021-0150
• Status: Completed
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: April 30, 2022

Study information

• Verified date: September 2023
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled trial (RCT) will compare the effects of melatonin vs. placebo in patients undergoing primary total knee arthroplasty (TKA). This RCT aims to study the effects melatonin has on sleep quality after TKA. Patients will be blinded to their respective groups and will be instructed to take either 5mg melatonin or a placebo pill (Vitamin C) for 6 weeks postoperative. Sleep quality surveys will be administered preoperatively and post-operative week 6, 90-days and 1 year. Poor sleep quality is a common issue faced by patients undergoing TKA. The goal of this study is see if melatonin can improve postoperative sleep quality, and if so, does improved sleep quality correlate to improvements in other postoperative outcomes.

Description:

This study will compare postoperative sleep quality in two groups of patients undergoing primary total knee arthroplasty (TKA):

• Group 1 will take one melatonin (5 mg) tablet nightly, ~30 minutes before bedtime during the 6 week postoperative period

• Group 2 will take one placebo (5 mg Vitamin C) tablet nightly, ~30 minutes before bedtime during the 6 week postoperative period

The primary outcome will be sleep quality at 6 weeks. Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). The survey will be administered preoperatively, 6-weeks, 90-days and 1 year postoperatively. Preoperative surveys will be completed in-person, on-site by study participants. All postoperative surveys will be distributed via email.

Secondary outcomes include:

• (KOOS Jr, LEAS, VR-12, VAS) administered preoperatively, at 6-weeks, 90-days and 1-year post-operatively.

• Total opioids prescribed in first 3 months postoperative will be collected using iStop

• Frequency of CMS defined surgicalcomplications in the first 90-days after primary TKA.

• Adverse events of Melatonin during the first 6 weeks (collected via email survey sent to participants once per week, for the first 6 weeks)

• Study medication compliance at 6 weeks (collected via email survey sent to participants once per week, for the first 6 weeks)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: April 30, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing primary, unilateral TKA

• Primary diagnosis of osteoarthritis (OA)

• Aged 18+

• Subject is opioid naive (has not taken opioids during the 6 months prior to surgery)

• Subject is not currently taking sleep medication

• English speaking

• Has working email (for survey purposes)

Exclusion Criteria:

• Patients with diagnosis other than OA including: Inflammatory arthritis; Post-traumatic OA; Chronic pain; Insomnia*; Depression*; Anxiety*; Any active sleep disorder

• Planned contralateral knee or subsequent total joint arthroplasty within 90 days

• Any planned surgery within 90 days

• Patient taking medication for depression or insomnia or anxiety during the 6 months prior to surgery

• Patients with renal or hepatic disorders as these can affect melatonin metabolism

• Insomnia, anxiety, and depression will be defined as use of controlled medication for that disorder which will be identified in istop or HSS record of the patient filled in the 6 months prior to surgery

Related Conditions & MeSH terms

• Arthroplasty
• Knee
• Replacement
• Sleep Initiation and Maintenance Disorders

Intervention

Dietary Supplement:
• Melatonin 5 mg
Participants will be taking one 5 mg tablet of Melatonin 30 minutes before bedtime nightly, for 6 weeks following their knee replacement surgeries.
• Placebo (Vitamin C)
Participants will be taking one placebo tablet 30 minutes before bedtime nightly, for 6 weeks following their knee replacement surgeries.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

References & Publications (6)

Hemati K, Pourhanifeh MH, Dehdashtian E, Fatemi I, Mehrzadi S, Reiter RJ, Hosseinzadeh A. Melatonin and morphine: potential beneficial effects of co-use. Fundam Clin Pharmacol. 2021 Feb;35(1):25-39. doi: 10.1111/fcp.12566. Epub 2020 Jun 21. — View Citation

Kirksey MA, Yoo D, Danninger T, Stundner O, Ma Y, Memtsoudis SG. Impact of Melatonin on Sleep and Pain After Total Knee Arthroplasty Under Regional Anesthesia With Sedation: A Double-Blind, Randomized, Placebo-Controlled Pilot Study. J Arthroplasty. 2015 Dec;30(12):2370-5. doi: 10.1016/j.arth.2015.06.034. Epub 2015 Jun 21. — View Citation

Luo ZY, Li LL, Wang D, Wang HY, Pei FX, Zhou ZK. Preoperative sleep quality affects postoperative pain and function after total joint arthroplasty: a prospective cohort study. J Orthop Surg Res. 2019 Nov 21;14(1):378. doi: 10.1186/s13018-019-1446-9. — View Citation

Mammoto T, Fujie K, Taguchi N, Ma E, Shimizu T, Hashimoto K. Short-Term Effects of Early Postoperative Celecoxib Administration for Pain, Sleep Quality, and Range of Motion After Total Knee Arthroplasty: A Randomized Controlled Trial. J Arthroplasty. 2021 Feb;36(2):526-531. doi: 10.1016/j.arth.2020.08.018. Epub 2020 Aug 18. — View Citation

Oh ES, Leoutsakos JM, Rosenberg PB, Pletnikova AM, Khanuja HS, Sterling RS, Oni JK, Sieber FE, Fedarko NS, Akhlaghi N, Neufeld KJ. Effects of Ramelteon on the Prevention of Postoperative Delirium in Older Patients Undergoing Orthopedic Surgery: The RECOVER Randomized Controlled Trial. Am J Geriatr Psychiatry. 2021 Jan;29(1):90-100. doi: 10.1016/j.jagp.2020.05.006. Epub 2020 May 16. — View Citation

Shakya H, Wang D, Zhou K, Luo ZY, Dahal S, Zhou ZK. Prospective randomized controlled study on improving sleep quality and impact of zolpidem after total hip arthroplasty. J Orthop Surg Res. 2019 Sep 3;14(1):289. doi: 10.1186/s13018-019-1327-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Quality	Assessed based on self-reported data collected using the Pittsburgh Sleep Quality Index (PSQI). Minimum Score: 0; Maximum Score: 21. Higher scores indicate a worse outcome.	Preoperatively
Primary	Sleep Quality	Assessed based on self-reported data collected using the Pittsburgh Sleep Quality Index (PSQI). Minimum Score: 0; Maximum Score: 21. Higher scores indicate a worse outcome.	6-week
Primary	Sleep Quality	Assessed based on self-reported data collected using the Pittsburgh Sleep Quality Index (PSQI). Minimum Score: 0; Maximum Score: 21. Higher scores indicate a worse outcome.	90 days
Primary	Sleep Quality	Assessed based on self-reported data collected using the Pittsburgh Sleep Quality Index (PSQI). Minimum Score: 0; Maximum Score: 21. Higher scores indicate a worse outcome.	1-year
Secondary	Knee Function	Assessed based on self-reported data collected using the abbreviated Knee Injury and Osteoarthritis Outcome Score (KOOS Jr). Minimum Score: 0; Maximum Score: 28. Higher scores indicate a better outcome.	Preoperatively, 6-week, 90-day and 1-year follow-up
Secondary	Lower Extremity Activity	Assessed based on self-reported data collected using the Lower Extremity Activity Scale (LEAS). Minimum Score: 1; Maximum Score: 18. Higher scores indicate a better outcome.	Preoperatively, 6-week, 90-day and 1-year follow-up
Secondary	Overall Health	Assessed based on self-reported data collected using the Veterans Rand 12 (VR-12) Scale. Minimum Score: 0; Maximum Score: 100. Higher scores indicate a better outcome.	Preoperatively, 6-week, 90-day and 1-year follow-up
Secondary	Pain Ratings	Assessed based on self-reported data collected using the Visual Analogue Pain Scale. Minimum Score: 0; Maximum Score: 10. Higher scores indicate a worse outcome.	Preoperatively, 6-week, 90-day and 1-year follow-up
Secondary	Opioids Prescribed	This will me quantified in morphine milligram equivalents (MMEs). This information will be obtained for each patient using institutionally queried i-Stop data.	90-day follow-up
Secondary	Quantity of Postoperative Centers for Medicare and Medicaid Services Complications	Assessed using institutional medical record data.	90-day follow-up
Secondary	Study Medication Compliance	Assessed based on self-reported data collected via study survey.	Weekly (Up to 6 weeks)
Secondary	Quantity of Adverse Melatonin Medical Events	Assessed based on self-reported data collected via study survey.	Weekly (Up to 6 weeks)