Butyrate and Taurine for Chronic Postsurgical Pain in Adult Cardiac Surgical Patients
Not yet recruitingNot applicableNCT07144033
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 co…
Study details
- Official title
- Butyrate and Taurine for Chronic Postsurgical Pain in Adult Cardiac Surgical Patients: Bayesian Optimized Double-blinded Randomized Controlled Trial
- Interventions
- Dietary supplement: Butyrate and Taurine
- Other: Placebo
- Sponsor
- Chinese University of Hong Kong
- Start date
- 2026-01-01
- Primary completion
- 2027-01-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Hong Kong
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07144033