- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07558512
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
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
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
-
-
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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
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:
- 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
Exclusion Criteria:
- 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
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
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
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)
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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
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)
April 16, 2026
Primary Completion (Actual)
April 25, 2026
Study Completion (Actual)
April 25, 2026
Study Registration Dates
First Submitted
April 23, 2026
First Submitted That Met QC Criteria
April 23, 2026
First Posted (Actual)
April 30, 2026
Study Record Updates
Last Update Posted (Actual)
May 8, 2026
Last Update Submitted That Met QC Criteria
May 4, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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