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Postoperative PainNCT07558512

Risk Factors and a Predictive Nomogram for Acute Moderate-to-severe Postoperative Pain After Achilles Tendon Surgery

An observational study of Postoperative Pain, run by Min Li at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-center retrospective cohort study to identify independent risk factors and develop a predictive nomogram for moderate-to-severe pain within 24 hours after Achilles tendon surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postoperative Pain
What is being tested?
No Study-Specific Intervention
How many people
489 participants
Where
1 siteChina
Study dates
16 Apr 2026to 25 Apr 2026
Phase
Observational
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

Study population: The study population consists of adult patients (≥18 years) who underwent Achilles tendon surgery at Peking University Third Hospital between January 2020 and December 2024. Eligible patients were those with complete perioperative data and standardized 24-hour postoperative pain assessments, meeting all inclusion and exclusion criteria of the study.

Who may be able to join

  • Age ≥ 18 years; American Society of Anesthesiologists (ASA) physical status classification Ⅰ~Ⅲ;
  • Clinically diagnosed with Achilles tendon rupture, Achilles tendinopathy, insertional Achilles tendinitis, Haglund's deformity, or other Achilles tendon disorders;
  • Undergoing open or arthroscopic Achilles tendon surgery;
  • Conscious and able to cooperate in surgery and postoperative pain assessment;
  • Complete and accessible case data related to surgery, anesthesia, and postoperative pain assessment;
  • Completion of at least 24 hours of standardized pain monitoring and clinical follow-up after surgery

Who cannot join

  • Missing or incomplete key clinical data such as pain assessment, surgery and anesthesia;
  • Failure to complete 24-hour standardized pain monitoring after surgery; Perioperative unplanned secondary surgery or transfer to the intensive care unit (ICU);
  • Patients with mental illness, cognitive dysfunction, or language communication barrier; History of alcohol or drug addiction Pain due to other acute or chronic diseases;
  • Bilateral Achilles tendon surgery Concurrent surgery for other lower extremity injuries

Trial locations and contacts

1 site in 1 country.

China1 site
  • Peking University Third Hospital

    Beijing, 100191

Other trials in China

About this study

Official title: Risk Factors and a Predictive Nomogram for Acute Moderate-to-severe Postoperative Pain Afte Achilles Tendon Surgery: A Retrospective Cohort Study

This is a single-center retrospective cohort study to identify independent risk factors and develop a predictive nomogram for moderate-to-severe pain within 24 hours after Achilles tendon surgery.

Being tested
No Study-Specific Intervention
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No Study-Specific InterventionOther

    This is a retrospective observational cohort study. No study-specific intervention is being investigated; all patients received routine clinical care as per standard practice.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Moderate-to-Severe Acute Postoperative Pain

    Defined as a pain score ≥ 4 on the Numeric Rating Scale (NRS) or the need for rescue analgesia within the first 24 hours after Achilles tendon surgery. The NRS is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate greater pain severity (worse outcome).

    Measured: Within 24 hours after surgery

Secondary outcomes (4)
  1. Highest Postoperative Pain Score

    The maximum pain score recorded within 24 hours after Achilles tendon surgery, measured using the Numeric Rating Scale (NRS). The NRS is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate greater pain severity (worse outcome).

    Measured: Within 24 hours after surgery

  2. Rescue Analgesia Requirement

    Proportion of patients requiring rescue analgesic medications within 24 hours after surgery.

    Measured: Within 24 hours after surgery

  3. Incidence of Postoperative Nausea and Vomiting (PONV)

    Proportion of patients experiencing nausea or vomiting requiring antiemetic treatment within 24 hours after surgery.

    Measured: Within 24 hours after surgery

  4. Postoperative Length of Hospital Stay

    Number of days from surgery to hospital discharge.

    Measured: From surgery to hospital discharge (up to 7 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2026
  2. Study start16 Apr 2026
  3. Primary completion25 Apr 2026
  4. Study completion25 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
489 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07558512
Sponsor's protocol ID
M20260277
Status last verified
May 2026
First submitted
23 Apr 2026
Last updated
8 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Pain, run by Min Li at 1 site in China.

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 6 inclusion and 4 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 8 May 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

Incidence of Moderate-to-Severe Acute Postoperative Pain (time frame: Within 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 8 May 2026.

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Clinical Trial NCT07558512 | AzTrials