Incidence of Chronic Pain After Sternotomy

Postoperative Pain Clinical Trial

Official title:

Incidence of Chronic Pain After Sternotomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05357963
• Other study ID #: E.Kurul-E1-22-2595
• Status: Recruiting
• Start date: April 20, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2024
• Source: Ankara City Hospital Bilkent
• Contact: Nilgün ZENGIN, MD
• Phone: +905063370548
• Email: nilbavullu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 1, 2024
• Est. primary completion date: July 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Pain, Postoperative
• Postoperative Pain
• Sternotomy

Intervention

Procedure:
• Sternotomy application
The chronic pain findings of the patients who underwent sternotomy will be questioned at the postoperative 3rd month.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Çankaya	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Acute pain score	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.	At the 24th hour after surgery