Butyrate and Taurine for Chronic Postsurgical Pain in Adult Cardiac Surgical Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
emergency surgery
redo surgery
history of chronic pain or on chronic opioids/sedatives
already taking taurine or butyrate prior to enrolment
Trial design
Design model
Parallel
Treatments tested in this trial
Butyrate and Taurine
Dietary supplementThis 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.
Placebo
Other interventionindistinguishable placebo capsules will be administered orally after enrolment on the day before surgery, followed by daily administration for three months after surgery.
Treatment groups
216 Participants
are divided into 2 treatment groupsGroup A: butyrate/taurine groupExperimental treatment 1 intervention
Group B: Placebo controlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Chronic postsurgical pain at 3 months
Incidence of chronic postsurgical pain based on the IASP definition
Time frame
At 3 months after surgerySecondary outcomes
1
chronic postsurgical pain at 1 month
Incidence of chronic postsurgical pain based on IASP definition
Time frame
At 1 month after surgery2
chronic postsurgical pain at 6 month
Incidence of chronic postsurgical pain based on IASP definition
Time frame
At 6 months after surgery3
chronic postsurgical pain at 12 month
Incidence of chronic postsurgical pain based on IASP definition
Time frame
At 12 months after surgery4
Brief Pain Inventory (BPI) at 1 month
The functional and affective interference of chronic postsurgical pain: the pain score is scaled from 0-10, the higher the score, the worse the pain. The functional and affective interference scale ranges from 0-10, the lower the score, the worse the performance
Time frame
At 1 month after surgerySponsors and contacts
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Source ClinicalTrials.gov
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