Postoperative Pain Management in Total Knee ArthroplastyPhase 4NCT07801742
EFFECT OF ZOLPIDEM ON SLEEP QUALITY AND OPIOID CONSUMPTION FOLLOWING PRIMARY TOTAL KNEE ARTHROPLASTY: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
A Phase 4 study testing Zolpidem 10 mg tablets and Avocado-soybean unsaponifiables 300 mg in people with Postoperative Pain Management in Total Knee Arthroplasty, run by Sanatorio Allende at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain Management in Total Knee Arthroplasty
- What is being tested?
- Zolpidem 10 mg tablets and Avocado-soybean unsaponifiables 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteArgentina
- Study dates
- 5 Aug 2025to 9 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Zolpidem 10 mg tablets, Avocado-soybean unsaponifiables 300 mg
- Keywords
- Zolpidem, Sleep quality, Postoperative pain, Total knee arthroplasty
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zolpidem 10 mg tabletsDrug
Zolpidem 10 mg was administered orally once nightly for 14 consecutive nights following total knee arthroplasty.
Avocado-soybean unsaponifiables 300 mgDrug
Avocado-soybean unsaponifiables (Prontal) 300 mg were administered orally once nightly for 14 consecutive nights following total knee arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants assigned to this arm received placebo orally once nightly for 14 consecutive nights after total knee arthroplasty. Receives: 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. Receives: Drug: Zolpidem 10 mg tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Postoperative days 7 and 14
Secondary outcomes (11)
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.
Measured: 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.
Measured: Postoperative days 7 and 14
Use of Rescue Tramadol
Use of rescue tramadol for postoperative pain management was recorded using a study-specific questionnaire.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postoperative days 7 and 14
Nocturnal Awakenings
Nocturnal awakenings during the postoperative period were assessed using a study-specific question
Measured: Postoperative days 7 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start5 Aug 2025
- Primary completion9 Jun 2026
- Study completion9 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain Management in Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanatorio Allende
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan pablo Melo, Sanatorio Allende
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801742
- Sponsor's protocol ID
- zolpidem_act_406
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 32883342Krenk 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.
PubMed 24634631
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF ZOLPIDEM ON SLEEP QUALITY AND OPIOID CONSUMPTION FOLLOWING PRIMARY TOTAL KNEE ARTHROPLASTY: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07801742
- Acronym / sponsor ID
- zolpidem_act_406
- Keywords
- Zolpidem, Sleep quality, Postoperative pain, Total knee arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Sanatorio AllendeUniversity, hospital or other
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 9 Jun 2026 (actual)
- Study completion
- 9 Jun 2026 (actual)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Avocado-soybean unsaponifiables 300 mgParticipants assigned to this arm received placebo orally once nightly for 14 consecutive nights after total knee arthroplasty. |
| Zolpidem | Experimental | Drug: Zolpidem 10 mg tabletsParticipants assigned to this arm received zolpidem 10 mg orally once nightly for 14 consecutive nights after total knee arthroplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zolpidem 10 mg tabletsZolpidem 10 mg was administered orally once nightly for 14 consecutive nights following total knee arthroplasty. | Drug | Zolpidem |
| Avocado-soybean unsaponifiables 300 mgAvocado-soybean unsaponifiables (Prontal) 300 mg were administered orally once nightly for 14 consecutive nights following total knee arthroplasty. | Drug | Placebo |
Primary outcome
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.
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.
11 secondary outcomes
Pain-Related Interference With Sleep
Time frame: Postoperative days 7 and 14
Postoperative Analgesic Consumption
Time frame: Postoperative days 7 and 14
Use of Rescue Tramadol
Time frame: Postoperative days 7 and 14
Participation in Postoperative Rehabilitation
Time frame: Postoperative days 7 and 14
Daily Duration of Postoperative Rehabilitation
Time frame: Postoperative days 7 and 14
Self-Reported Mobility Compared With Hospital Discharge
Time frame: Postoperative days 7 and 14
Patient Satisfaction With Sleep Quality Assessed Using a 5-Point Likert Scale
Time frame: Postoperative days 7 and 14
Patient Satisfaction With Pain Management Assessed Using a 5-Point Likert Scale
Time frame: Postoperative days 7 and 14
Number of Participants With Treatment-Related Adverse Events
Time frame: Through postoperative day 14
Average Sleep Duration
Time frame: Postoperative days 7 and 14
Nocturnal Awakenings
Time frame: Postoperative days 7 and 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Background: PubMed 32883342O'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.
- Background: PubMed 24634631Krenk 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zolpidem 10 mg tablets and Avocado-soybean unsaponifiables 300 mg in people with Postoperative Pain Management in Total Knee Arthroplasty, run by Sanatorio Allende at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity Assessed Using the Numeric Rating Scale (time frame: Postoperative days 7 and 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07801742, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.