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

May 4, 2026 updated by: Min Li

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
489

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100191
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Moderate-to-Severe Acute Postoperative Pain
Time Frame: Within 24 hours after surgery
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).
Within 24 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rescue Analgesia Requirement
Time Frame: Within 24 hours after surgery
Proportion of patients requiring rescue analgesic medications within 24 hours after surgery.
Within 24 hours after surgery
Incidence of Postoperative Nausea and Vomiting (PONV)
Time Frame: Within 24 hours after surgery
Proportion of patients experiencing nausea or vomiting requiring antiemetic treatment within 24 hours after surgery.
Within 24 hours after surgery
Postoperative Length of Hospital Stay
Time Frame: From surgery to hospital discharge (up to 7 days)
Number of days from surgery to hospital discharge.
From surgery to hospital discharge (up to 7 days)
Highest Postoperative Pain Score
Time Frame: Within 24 hours after surgery
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).
Within 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Min Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M20260277

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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