MedTrace Logo

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

NCT07801742 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-09-03

No results posted yet for this study

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.

Conditions

  • Postoperative Pain Management in Total Knee Arthroplasty

Interventions

DRUG

Zolpidem 10 mg tablets

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

DRUG

Avocado-soybean unsaponifiables 300 mg

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

Sponsors & Collaborators

  • Sanatorio Allende

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-05
Primary Completion
2026-06-09
Completion
2026-06-09

Countries

  • Argentina

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07801742 on ClinicalTrials.gov