Incidence of Chronic Pain After Sternotomy

NCT05357963 | Completed

• 1 other identifier: E.Kurul-E1-22-2595
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic postoperative pain is a well-known problem. Chronic postoperative pain is defined as pain that begins following a surgical procedure and persists for more than 2 months without other obvious causes such as infection or underlying disease. Sternotomy causes significant postoperative pain, and patients with chronic pain after sternotomy are often referred to pain clinics. The incidence of chronic pain after sternotomy ranges from 17% to 56%; In approximately one-third of these patients, chronic pain after sternotomy can compromise their quality of life by affecting their sleep patterns and impairing their ability to work. However, epidemiological studies on chronic pain after sternotomy are scarce. The aim of this study is to examine the incidence and possible risk factors of chronic pain following sternotomy operations. In this study, it was aimed to analyze the chronic pain findings of the patients who underwent sternotomy in the postoperative 3rd month.

Conditions

Postoperative Pain; Postoperative Pain, Acute; Postoperative Pain, Chronic; Sternotomy

Outcome Measures

Primary Outcomes (2)

• Chronic pain symptoms at 3rd months.

  Chronic pain symptoms will be assessed using the numeric rating scale on a scale from 0 (no pain) to 10 (worst pain). Chronic pain symptoms (burning, stabbing, electric shock-like pain, tingling, numbness, pins, and needles feeling, hyperalgesia, allodynia, and hypoesthesia) will also be asked to the patients at the 3rd month after surgery.

  Chronic pain symptoms at 3rd month

• Quality of life at 3rd months.

  It will also be questioned whether the current pain of the patients affects their daily activities. It will be coded as '0 = not at all, 1 = slightly affecting, 2 = very affecting'.

  Quality of life at 3rd months.

Secondary Outcomes (1)

• Acute pain score

  At the 24th hour after surgery

Interventions

Sternotomy application PROCEDURE

The chronic pain findings of the patients who underwent sternotomy will be questioned at the postoperative 3rd month.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients between the ages of 18-80 years, in the ASA I-II-III-IV risk group, with a BMI between 18-35 kg/m2 and undergoing sternotomy will be included in the study. Patients under the age of 18 years and over the age of 80 years, with an ASA score of V and above, with a BMI below 18 kg/m2 and above 35 kg/m2, who were operated under emergency conditions, and who received chronic pain treatment will be excluded from the study.

You may qualify if:

• Age between 18 and 80 years
• American Society of Anesthesiologists' physical status I-II-III-IV
• Body mass index (BMI) between 18-35 kg/m2
• Patients undergoing elective sternotomy

You may not qualify if:

• History of chronic analgesic therapy
• Patients with previous sternotomy surgery
• Patients who were operated under emergency conditions

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Çankaya, Ankara, 06290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Nilgün ZENGİN, MD

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 3, 2022
• Study Start: April 20, 2022
• Primary Completion: November 5, 2025
• Study Completion: February 5, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

TU (1)