Effects of Melatonin on Sleep Quality and Patient-Reported Outcomes After Arthroscopic Rotator Cuff Surgery: A Prospective Randomized Controlled Trial.
Study Goal
To investigate the effects of oral melatonin on postoperative sleep quality and functional outcomes after arthroscopic rotator cuff repair.
Results Summary
Melatonin improved sleep quality (PSQI) in the early postoperative period and enhanced functional outcomes (ASES and SANE scores) while reducing narcotic use in the later postoperative period.
Population
Patients undergoing arthroscopic rotator cuff repair, excluding those with alcohol abuse, current antidepressant/sedative use, revision surgery, severe arthritis, or adhesive capsulitis.
Effective Dosage
5 mg taken 1 hour before bedtime.
Duration
6 weeks beginning the day of surgery.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
oral melatonin | increase | sleep quality (PSQI) | patients undergoing arthroscopic rotator cuff repair | - | led to improved | #1 |
oral melatonin | increase | functional outcomes (ASES and SANE scores) | patients undergoing arthroscopic rotator cuff repair | - | led to improved | #2 |
oral melatonin | decrease | narcotic use | patients undergoing arthroscopic rotator cuff repair | - | led to decreased | #3 |
BACKGROUND: Sleep disturbance is a significant symptom associated with both rotator cuff tears and arthroscopic rotator cuff repair. Melatonin has been shown to be safe and effective in managing multiple sleep disorders, including secondary sleep disorders, with relatively minor adverse effects and lack of addictive potential. PURPOSE: To investigate the effects of oral melatonin on postoperative sleep quality after arthroscopic rotator cuff repair. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: This was a prospective randomized clinical trial evaluating patients undergoing arthroscopic rotator cuff repair. Exclusion criteria included history of alcohol abuse, current antidepressant or sedative use, revision rotator cuff repair, severe glenohumeral arthritis, and concurrent adhesive capsulitis. Patients were randomly assigned in a 1:1 ratio to 1 of 2 groups: 5-mg dose of melatonin 1 hour before bedtime or standard sleep hygiene (≥6 hours per night, avoiding caffeine and naps in the evening). Patients in the melatonin group took their assigned melatonin dose for 6 weeks beginning the day of surgery. Patient-reported outcome assessments, including the Pittsburgh Sleep Quality Index (PSQI), the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), and the Single Assessment Numeric Evaluation (SANE), and pain medication charts were collected preoperatively as well as at 2 weeks, 6 weeks, 3 months, 4 months, and 6 months postoperatively. Numeric variables were analyzed using paired and unpaired RESULTS: Eighty patients were included for final analysis (40 in the control group, 40 in the melatonin group). Patient characteristics such as age, sex, race, body mass index, and laterality did not differ significantly ( CONCLUSION: Melatonin use after arthroscopic rotator cuff repair led to improved sleep quality (PSQI) in the early postoperative period as well as improved functional outcomes (ASES and SANE scores) and decreased narcotic use in the later postoperative period. Patients with significant sleep disturbances associated with rotator cuff repairs may benefit from the use of melatonin. REGISTRATION: NCT04278677 (ClinicalTrials.gov identifier).