Incidence of Chronic Pain After Sternotomy

Recruiting

• Conditions: Postoperative Pain; Sternotomy; Postoperative Pain, Chronic; Postoperative Pain, Acute

• Registration Number: NCT05357963
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-20
• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-04-28
• Study First Posted: 2022-05-03
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02
• Primary Completion: 2024-07-20
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chronic pain symptoms at 3rd months.	Chronic pain symptoms at 3rd month	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.
Quality of life at 3rd months.	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'.

Secondary Outcome Measures

Name	Time	Method
Acute pain score	At the 24th hour after surgery	Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at the 24th hour after surgery.

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Çankaya, Ankara, Turkey