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OpenTrials
Completed

NCT Number: NCT07801742

EFFECT OF ZOLPIDEM ON SLEEP QUALITY AND OPIOID CONSUMPTION FOLLOWING PRIMARY TOTAL KNEE ARTHROPLASTY: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

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.

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Key information

Conditions

Postoperative Pain Management in Total Knee Arthroplasty Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanatorio Allende

Córdoba, Córdoba Province, 5000, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zolpidem 10 mg tablets

Drug

Zolpidem 10 mg was administered orally once nightly for 14 consecutive nights following total knee arthroplasty.

Avocado-soybean unsaponifiables 300 mg

Drug

Avocado-soybean unsaponifiables (Prontal) 300 mg were administered orally once nightly for 14 consecutive nights following total knee arthroplasty.

Primary outcomes

  1. Postoperative Pain Intensity Assessed Using the Numeric Rating Scale

    Time frame: 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.

  2. Postoperative Sleep Quality Assessed Using a 5-Point Likert Scale

    Time frame: 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 outcomes

  1. Pain-Related Interference With Sleep

    Time frame: 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.

  2. Postoperative Analgesic Consumption

    Time frame: 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.

  3. Use of Rescue Tramadol

    Time frame: Postoperative days 7 and 14

    Use of rescue tramadol for postoperative pain management was recorded using a study-specific questionnaire.

  4. Participation in Postoperative Rehabilitation

    Time frame: 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.

  5. Daily Duration of Postoperative Rehabilitation

    Time frame: 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.

  6. Self-Reported Mobility Compared With Hospital Discharge

    Time frame: 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.

  7. Patient Satisfaction With Sleep Quality Assessed Using a 5-Point Likert Scale

    Time frame: 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.

  8. Patient Satisfaction With Pain Management Assessed Using a 5-Point Likert Scale

    Time frame: 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.

  9. Number of Participants With Treatment-Related Adverse Events

    Time frame: 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.

  10. Average Sleep Duration

    Time frame: 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.

  11. Nocturnal Awakenings

    Time frame: Postoperative days 7 and 14

    Nocturnal awakenings during the postoperative period were assessed using a study-specific question

Sponsors and collaborators

Lead sponsor

Sanatorio Allende

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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