This clinical trial evaluated whether zolpidem could improve sleep quality and postoperative recovery in patients undergoing total joint arthroplasty. Participants were randomly assigned to receive either zolpidem 10 mg or a placebo for 14 nights, beginning after hospital discharge. Neither the participants nor their physicians knew which treatment was assigned. The study assessed sleep quality and duration, postoperative pain, use of pain medications, functional recovery, satisfaction, and adverse events. The study hypothesis was that improving sleep with zolpidem would lead to better sleep and potentially improve pain control and recovery after surgery compared with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
54
Zolpidem 10 mg was administered orally once nightly for 14 consecutive nights following total knee arthroplasty.
Avocado-soybean unsaponifiables (Prontal) 300 mg were administered orally once nightly for 14 consecutive nights following total knee arthroplasty.
Sanatorio Allende
Córdoba, Córdoba Province, Argentina
Postoperative Pain Intensity Assessed Using the Numeric Rating Scale
Postoperative pain intensity was assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicated greater pain intensity.
Time frame: Postoperative days 7 and 14
Postoperative Sleep Quality Assessed Using a 5-Point Likert Scale
Overall postoperative sleep quality was assessed using a study-specific question rated on a 5-point Likert scale. The question was selected with reference to conceptual domains of the Pittsburgh Sleep Quality Index (PSQI); however, the PSQI itself was not administered or scored. Higher scores indicated better perceived sleep quality.
Time frame: Postoperative days 7 and 14
Pain-Related Interference With Sleep
Pain-related interference with sleep was assessed using a study-specific question evaluating whether postoperative pain interfered with the patient's sleep.
Time frame: Postoperative days 7 and 14
Postoperative Analgesic Consumption
Postoperative analgesic consumption was assessed using a study-specific questionnaire recording the patient's use of analgesic medication during the postoperative period.
Time frame: Postoperative days 7 and 14
Use of Rescue Tramadol
Use of rescue tramadol for postoperative pain management was recorded using a study-specific questionnaire.
Time frame: Postoperative days 7 and 14
Participation in Postoperative Rehabilitation
Participation in postoperative rehabilitation was assessed using a study-specific questionnaire recording whether the patient was participating in rehabilitation activities.
Time frame: Postoperative days 7 and 14
Daily Duration of Postoperative Rehabilitation
The duration of postoperative rehabilitation was assessed by patient report and recorded as the average number of minutes of rehabilitation performed per day.
Time frame: Postoperative days 7 and 14
Self-Reported Mobility Compared With Hospital Discharge
Postoperative mobility was assessed using a study-specific question in which patients reported their mobility relative to their mobility at the time of hospital discharge.
Time frame: Postoperative days 7 and 14
Patient Satisfaction With Sleep Quality Assessed Using a 5-Point Likert Scale
Patient satisfaction with postoperative sleep quality was assessed using a study-specific 5-point Likert scale. Higher scores indicated greater satisfaction with sleep quality.
Time frame: Postoperative days 7 and 14
Patient Satisfaction With Pain Management Assessed Using a 5-Point Likert Scale
Patient satisfaction with postoperative pain management was assessed using a study-specific 5-point Likert scale. Higher scores indicated greater satisfaction with pain management.
Time frame: Postoperative days 7 and 14
Number of Participants With Treatment-Related Adverse Events
Treatment-related adverse events were assessed using study-specific questions. Recorded events included daytime somnolence, falls, confusion, and other patient-reported complications.
Time frame: Through postoperative day 14
Average Sleep Duration
Average postoperative sleep duration was assessed by patient self-report using a study-specific question and recorded as the average number of hours slept.
Time frame: Postoperative days 7 and 14
Nocturnal Awakenings
Nocturnal awakenings during the postoperative period were assessed using a study-specific question
Time frame: Postoperative days 7 and 14
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