NCT07144033 Butyrate and Taurine for Chronic Postsurgical Pain in Adult Cardiac Surgical Patients
| NCT ID | NCT07144033 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Pain, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 216 participants |
| Start Date | 2026-06-20 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 216 participants in total. It began in 2026-06-20 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Adult patients aged 18 or older * elective surgery * coronary artery bypass graft (CABG), valve repair/replacement, combined CABG/valve procedure, or major aortic procedure via sternotomy Exclusion Criteria: * emergency surgery * redo surgery * history of chronic pain or on chronic opioids/sedatives * already taking taurine or butyrate prior to enrolment * renal failure with estimated glomerular filtration rate \<30mL/min (calculated by Cockcroft-Gault formula) * re-operation within 24 hours after surgery * intraoperative use of remifentanil * inability to provide informed consent.
Contact & Investigator
Henry Wong, MBChB
PRINCIPAL INVESTIGATOR
Department of Anaesthesia and Intensive Care, The Chinese University of Hong Hong
Frequently Asked Questions
Who can join the NCT07144033 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pain, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07144033 currently recruiting?
Yes, NCT07144033 is actively recruiting participants. Contact the research team at henrymkwong@cuhk.edu.hk for enrollment information.
Where is the NCT07144033 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT07144033 clinical trial?
NCT07144033 is sponsored by Chinese University of Hong Kong. The principal investigator is Henry Wong, MBChB at Department of Anaesthesia and Intensive Care, The Chinese University of Hong Hong. The trial plans to enroll 216 participants.