Incidence of Chronic Pain After Sternotomy

Sponsor
Ankara City Hospital Bilkent (Other)
Overall Status
Recruiting
CT.gov ID
NCT05357963
Collaborator
(none)
200
1
9.4
21.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Sternotomy application

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Incidence of Chronic Pain After Sternotomy
Actual Study Start Date :
Apr 20, 2022
Anticipated Primary Completion Date :
Jan 20, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara City Hospital Çankaya Ankara Turkey 06290

Sponsors and Collaborators

  • Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Nilgün ZENGİN, MD, Ankara City Hospital Bilkent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nilgün Zengin, Principal İnvestigator, Ankara City Hospital Bilkent
ClinicalTrials.gov Identifier:
NCT05357963
Other Study ID Numbers:
  • E.Kurul-E1-22-2595
First Posted:
May 3, 2022
Last Update Posted:
May 3, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2022