Postoperative Pain Management in Total Knee Arthroplasty
Conditions
Keywords
Zolpidem, Sleep quality, Postoperative pain, Total knee arthroplasty
Brief summary
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.
Interventions
Zolpidem 10 mg was administered orally once nightly for 14 consecutive nights following total knee arthroplasty.
DRUGAvocado-soybean unsaponifiables 300 mg
Avocado-soybean unsaponifiables (Prontal) 300 mg were administered orally once nightly for 14 consecutive nights following total knee arthroplasty.
Sponsors
Sanatorio Allende
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years. * Undergoing primary total knee arthroplasty (TKA). * Ability to understand the study procedures. * Ability to provide written informed consent. * Ability to complete the postoperative questionnaires.
Exclusion criteria
* History of hypersensitivity to zolpidem or other hypnotic agents. * Revision total knee arthroplasty. * Arthroplasty performed for fracture. * Preoperative use of sleep medications. * Obstructive sleep apnea. * Severe respiratory insufficiency. * Severe hepatic disease. * Cognitive impairment preventing reliable assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity Assessed Using the Numeric Rating Scale | Postoperative days 7 and 14 | 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. |
| Postoperative Sleep Quality Assessed Using a 5-Point Likert Scale | Postoperative days 7 and 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain-Related Interference With Sleep | Postoperative days 7 and 14 | Pain-related interference with sleep was assessed using a study-specific question evaluating whether postoperative pain interfered with the patient's sleep. |
| Postoperative Analgesic Consumption | Postoperative days 7 and 14 | Postoperative analgesic consumption was assessed using a study-specific questionnaire recording the patient's use of analgesic medication during the postoperative period. |
| Use of Rescue Tramadol | Postoperative days 7 and 14 | Use of rescue tramadol for postoperative pain management was recorded using a study-specific questionnaire. |
| Participation in Postoperative Rehabilitation | Postoperative days 7 and 14 | Participation in postoperative rehabilitation was assessed using a study-specific questionnaire recording whether the patient was participating in rehabilitation activities. |
| Daily Duration of Postoperative Rehabilitation | Postoperative days 7 and 14 | The duration of postoperative rehabilitation was assessed by patient report and recorded as the average number of minutes of rehabilitation performed per day. |
| Self-Reported Mobility Compared With Hospital Discharge | Postoperative days 7 and 14 | 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. |
| Patient Satisfaction With Sleep Quality Assessed Using a 5-Point Likert Scale | Postoperative days 7 and 14 | Patient satisfaction with postoperative sleep quality was assessed using a study-specific 5-point Likert scale. Higher scores indicated greater satisfaction with sleep quality. |
| Patient Satisfaction With Pain Management Assessed Using a 5-Point Likert Scale | Postoperative days 7 and 14 | Patient satisfaction with postoperative pain management was assessed using a study-specific 5-point Likert scale. Higher scores indicated greater satisfaction with pain management. |
| Number of Participants With Treatment-Related Adverse Events | Through postoperative day 14 | Treatment-related adverse events were assessed using study-specific questions. Recorded events included daytime somnolence, falls, confusion, and other patient-reported complications. |
| Average Sleep Duration | Postoperative days 7 and 14 | Average postoperative sleep duration was assessed by patient self-report using a study-specific question and recorded as the average number of hours slept. |
| Nocturnal Awakenings | Postoperative days 7 and 14 | Nocturnal awakenings during the postoperative period were assessed using a study-specific question |
Countries
Argentina
Outcome results
None listed