Butyrate and Taurine for Chronic Postsurgical Pain in Adult Cardiac Surgical Patients

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.

Conditions

• Pain, Acute
• Pain, Chronic
• Chronic Post Operative Pain

Interventions

DIETARY_SUPPLEMENT

Butyrate and Taurine

This dose of butyrate is chosen to maximize any treatment effect in postoperative pain. Butyrate was reported to be safe at this dose for a prolonged period of 8 weeks. The dose of taurine is considered safe according to the European Food Safety Authority and was used in previous human perioperative trials. A human pharmacokinetic study showed that after taking 4g taurine (32 mmol) orally, plasma taurine levels reached a peak level of 86 mg/L (or 0.7 mmol/L) at 1.5 hours, exceeding the physiological plasma taurine level (0.01-0.1 mmol/L), which is needed to exert its pharmacological benefits.

OTHER

Placebo

indistinguishable placebo capsules will be administered orally after enrolment on the day before surgery, followed by daily administration for three months after surgery.

Sponsors & Collaborators

• Chinese University of Hong Kong

  lead OTHER

Principal Investigators

• Henry Wong, MBChB · Department of Anaesthesia and Intensive Care, The Chinese University of Hong Hong

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2027-01-31

Completion

2028-01-31

Countries

• Hong Kong

Study Locations