About this trial

This survey study aims to investigate the incidence of Chronic post surgical pain (CPSP) in cardiac surgery patients treated at UZ Leuven. The primary hypothesis is that the incidence of CPSP at 3 months postoperatively is lower than 33%, which is the rate commonly reported in the literature. Secondary objectives include comparing CPSP incidence based on the type of surgical incision, as well as comparing incidences between type of surgery. Finally, the study will assess pain intensity, interference with daily activities, and quality of life of 3 months and when required also at 1 years postoperatively.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults, aged ≥ 18 years of age, who underwent cardiac surgery (valvular, coronary bypass, other intracardiac or aortic surgery) during the 1 year recruitment period

Able to provide informed consent

Able to respond by telephone

Disqualifiers

Deceased

Refusal

Chronic pain in the surgical region

Trial population

The study will include all adult patients undergoing cardiac surgery over a 1-year period at UZ Leuven, totaling approximately 1200 cases. With an expected response rate of 80%, the final sample size is estimated at 1000 patients. This sample size is considered sufficient to obtain robust estimates of both early and long-term incidence of CPSP following cardiac surgery at UZ Leuven to support future prospective studies.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants

are grouped into 1 trial group

Group A: Cardiac surgery

Trial outcomes

Primary outcomes

1

Incidence of chronic post surgical pain

Numerical rating scale (NRS) for pain (persistent or recurrent) longer than 3 months present, the apin began or increased in intensity after surgery, the pain is in the surgical area and persisted for at least 3 months after the initiation event, and is not better accounted for by an infection, malignancy, a pre-existing pain condition or alternative.

Time frame

3 months

Secondary outcomes

1

Chronic post surgical pain

Numerical rating scale (NRS) for pain (persistent or recurrent) longer than 3 months present, the apin began or increased in intensity after surgery, the pain is in the surgical area and persisted for at least 3 months after the initiation event, and is not better accounted for by an infection, malignancy, a pre-existing pain condition or alternative.

Time frame

1 year

2

Brief pain inventory (BPI)

Details from the BPI (short-form) will be evaluated via telephone call during which pain severity score (mean of items worst pain, least pain and current pain) and pain interference score (mean of interference of pain with general activity, mood, walking, work, relations, sleep enjoyment of life) will be assessed. All items will be assessed on a score of 0-10, with 0 being no pain or interference and 10 the worst pain or impact.

Time frame

3 months

3

Quality of life 5-level EQ-5D version (EQ-5D-5L)

The EQ-5D-5L evaluates Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. These domains are score on 5 levels (no problem (1) to extreme problem (5), with higher numbers indicating worse health status. A patient rated assessment of they overall health EQ visual analoge score (EQ VAS) with 0 being the worst score up to 100 being the best score. The digits-string of the EQ-5D-5L is converted into a single index value based on the Belgian set to have a country-specific scoring algorithm with max of 1.0, reflecting perfect health, down to negative (-0.59) values representing health status 'worse than dead'.

Time frame

3 months

4

Brief pain inventory (BPI)

Details from the BPI (short-form) will be evaluated via telephone call during which pain severity score (mean of items worst pain, least pain and current pain) and pain interference score (mean of interference of pain with general activity, mood, walking, work, relations, sleep enjoyment of life) will be assessed. All items will be assessed on a score of 0-10, with 0 being no pain or interference and 10 the worst pain or impact.

Time frame

1 year

Cardiac Surgery, the Incidence and Impact of Chronic postOperative Pain: a Survey

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial population

Trial design

Treatments tested in this trial

Trial groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts