Incidence and Risk Factors for Persistent Post-sternotomy Pain After Cardiac Surgery in Local Chinese Population: a Prospective Cohort Study

NCT04644666 | Unknown

• 1 other identifier: 2020.446-T
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

CPSP is common after cardiac surgery. The reported incidence was 28% to 56% up to 2 years postoperatively. Despite a large number of cross-sectional and retrospective studies, prospective cohort studies examining the incidence of chronic post-sternotomy pain following cardiac surgery have been scarce, and none on our local Chinese population. Several mechanisms have been involved in the development of chronic pain after sternotomy. Ongoing pain after surgery can continue to sensitize the nociceptive fibres which may subsequently lead to hyperalgesia, hyperpathia, allodynia and dysesthesia. In addition, like any form of chronic pain, it is a multidimensional process involving social, cognitive and psychological factors. CPSP has the potential to impact daily functioning and quality of life of patients, as well as increasing the healthcare costs. To date, only the CARDpain study examined the role of social and psychological risk factors in development of CPSP after cardiac surgery. They found pre-surgical anxiety, measured by the Hospital and Anxiety Depression Scale (HADS), was a significant risk factor. The primary aim of the study is to examine the incidence of chronic post-sternotomy pain at 3 months and 6 months following cardiac surgery in local Chinese population, and identify the clinical and psychological risk factors associated with its development. The secondary aim is to determine the impact of CPSP on the quality of life following cardiac surgery.

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (4)

• Incidence of chronic post-sternotomy pain in number

  Number of recruited patients who have chronic pain

  3 months after surgery

• Incidence of chronic post-sternotomy pain in percentage

  Percentage of recruited patients who have chronic pain

  3 months after surgery

• Incidence of chronic post-sternotomy pain

  Number of recruited patients who have chronic pain

  6 months after surgery

• Incidence of chronic post-sternotomy pain

  Percentage of recruited patients who have chronic pain

  6 months after surgery

Secondary Outcomes (4)

• Association between the severity of acute postoperative pain (measured using visual analogue scale) and the presence of chronic post-surgical pain

  Acute postoperative pain captured within 72 hours and on Day 7 after surgery using visual analogue score

• Association between the amount of intraoperative and postoperative opioid consumption and the presence of chronic post-surgical pain

  Opioid consumption during surgery and within 72 hours after surgery will be captured

• Association between psychological risk factors and chronic post-surgical pain

  Hospital Anxiety and Depression Scale will be assessed 1 day before surgery, 3 month postop and 6 month postop

• Association between psychological risk factors and chronic post-surgical pain

  EQ-5D questionnaire will be assessed 1 day before surgery, 3 month postop and 6 month postop

Eligibility Criteria

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

Study Population

Local Chinese population age 18 or older undergoing elective open heart surgery

You may qualify if:

• Adult patients aged 18 or older
• Elective surgery
• Primary isolated coronary artery bypass grafting, aortic valve repair/replacement or combined coronary artery bypass/valve procedure via sternotomy for the first time

You may not qualify if:

• Emergency surgery
• Redo surgery
• History of thoracotomy or mastectomy
• History of psychosis or illicit drug use
• Estimated glomerular filtration rate (eGFR) \<30ml/min or on renal replacement therapy. This is calculated using Cockcroft-Gault formula
• Intraoperative use of remifentanil
• Unable to provide informed consent and complete the questionnaires because of physical or mental incapacity

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Clinical Associate Professor, Associate Consultant

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 25, 2020
• Study Start: December 1, 2020
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

HK (1)