NCT07801742

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
Last Updated

September 3, 2026

Status Verified

August 1, 2026

Enrollment Period

10 months

First QC Date

August 31, 2026

Last Update Submit

August 31, 2026

Conditions

Postoperative Pain Management in Total Knee Arthroplasty

Keywords

ZolpidemSleep qualityPostoperative painTotal knee arthroplasty

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Postoperative days 7 and 14

Secondary Outcomes (11)

  • Pain-Related Interference With Sleep

    Postoperative days 7 and 14

  • Postoperative Analgesic Consumption

    Postoperative days 7 and 14

  • Use of Rescue Tramadol

    Postoperative days 7 and 14

  • Participation in Postoperative Rehabilitation

    Postoperative days 7 and 14

  • Daily Duration of Postoperative Rehabilitation

    Postoperative days 7 and 14

  • +6 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants assigned to this arm received placebo orally once nightly for 14 consecutive nights after total knee arthroplasty.

Drug: Avocado-soybean unsaponifiables 300 mg

Zolpidem

EXPERIMENTAL

Participants assigned to this arm received zolpidem 10 mg orally once nightly for 14 consecutive nights after total knee arthroplasty.

Drug: Zolpidem 10 mg tablets

Interventions

Zolpidem 10 mg tabletsDRUG

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

Zolpidem
Avocado-soybean unsaponifiables 300 mgDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanatorio Allende

Córdoba, Córdoba Province, 5000, Argentina

Location

Related Publications (2)

  • O'Hagan ET, Hubscher M, Miller CB, Gordon CJ, Gustin S, Briggs N, McAuley JH. Zolpidem reduces pain intensity postoperatively: a systematic review and meta-analysis of the effect of hypnotic medicines on post-operative pain intensity. Syst Rev. 2020 Sep 3;9(1):206. doi: 10.1186/s13643-020-01458-8.

    PMID: 32883342BACKGROUND

  • Krenk L, Jennum P, Kehlet H. Postoperative sleep disturbances after zolpidem treatment in fast-track hip and knee replacement. J Clin Sleep Med. 2014 Mar 15;10(3):321-6. doi: 10.5664/jcsm.3540.

    PMID: 24634631BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersPain, Postoperative

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Orthopedic Surgeon

Study Record Dates

First Submitted

August 31, 2026

First Posted

September 3, 2026

Study Start

August 5, 2025

Primary Completion

June 9, 2026

Study Completion

June 9, 2026

Last Updated

September 3, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Deidentified individual participant data (IPD) that underlie the results reported in the published article will be made available. The shared dataset may include baseline demographic and clinical characteristics, treatment allocation, postoperative sleep and pain assessments, analgesic use, rehabilitation and mobility outcomes, patient satisfaction, and reported adverse events. All data will be deidentified prior to sharing to protect participant confidentiality. No personally identifiable information will be shared.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning 6 months after publication of the study results and will remain available for 5 years.
Access Criteria
Deidentified individual participant data and supporting information will be made available to qualified researchers upon reasonable request to the corresponding author. Requests should include a brief research proposal describing the purpose of the analysis and the data requested. Access will be granted following review and approval by the study investigators, provided that the proposed use is scientifically appropriate and consistent with participant confidentiality and applicable ethical requirements.

Locations

AR(1)