This study is a single-center, phase II, randomized, placebo-controlled, Bayesian-designed, double-blinded trial
Goal and Questions:
The primary goal is to evaluate if a combination of taurine and butyrate can reduce chronic postsurgical pain (CPSP) in adult cardiac surgical patients. The study also aims to determine if these compounds are safe, effective in perioperative pain control, and feasible for improving postoperative outcomes.
Participants:
The study will include adult patients (aged 18 or older) undergoing elective coronary artery bypass graft (CABG), valve repair/replacement, combined CABG/valve, or major aortic procedure via sternotomy. Exclusion criteria include emergency surgery, redo surgery, a history of chronic pain or chronic opioid/sedative use, and an estimated glomerular filtration rate (eGFR) less than 30 mL/min. The target sample size is 216 patients.
Intervention group: Patients will receive 4g of taurine and 4.8g of sodium butyrate orally once daily, starting the day before surgery and continuing for three months post-surgery.
Placebo group: Patients will receive indistinguishable placebo capsules orally once daily, following the same schedule as the intervention group.
Primary Outcome: The incidence of chronic postsurgical pain at 3 months,
Secondary Outcomes:
Quality of Recovery Questionnaire (QoR-15) at 72 hours after extubation.
Pain scores (NRS) at rest and with movement at 12, 24, 48, and 72 hours post-extubation.
Postoperative morphine requirements and time to first morphine rescue.
Incidence of opioid-related side effects, such as postoperative nausea and vomiting (PONV).
Duration of mechanical ventilation, and length of stay in the ICU and hospital.
Long-term pain assessment using the Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2), Brief Pain Inventory (BPI) Interference Scale, and Neuropathic Pain Questionnaire (NPQ) at 1, 3, 6, and 12 months post-surgery
Proteomic analysis:
Blood samples within 72 hours after surgery will be collected for proteomic analysis to investigate predictors for chronic postsurgical pain.