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

NCT07558512 | Not Yet Recruiting

• 1 other identifier: M20260277
• Study Type: observational
• Target: 489
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (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).

  Within 24 hours after surgery

Secondary Outcomes (4)

• Highest Postoperative Pain Score

  Within 24 hours after surgery

• Rescue Analgesia Requirement

  Within 24 hours after surgery

• Incidence of Postoperative Nausea and Vomiting (PONV)

  Within 24 hours after surgery

• Postoperative Length of Hospital Stay

  From surgery to hospital discharge (up to 7 days)

Interventions

No Study-Specific Intervention OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Min Li: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, Department of Anesthesiology

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start: April 25, 2026
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): June 25, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04