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

NCT07144033 | Not Yet Recruiting DMC

• 1 other identifier: 2025.335-T
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute; Pain, Chronic; Chronic Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Chronic postsurgical pain at 3 months

  Incidence of chronic postsurgical pain based on the IASP definition

  At 3 months after surgery

Secondary Outcomes (41)

• chronic postsurgical pain at 1 month

  At 1 month after surgery

• chronic postsurgical pain at 6 month

  At 6 months after surgery

• chronic postsurgical pain at 12 month

  At 12 months after surgery

• Brief Pain Inventory (BPI) at 1 month

  At 1 month after surgery

• Brief Pain Inventory (BPI) at 3 month

  At 3 month after surgery

Study Arms (2)

butyrate/taurine group

EXPERIMENTAL

Interventional group (combination of taurine and butyrate): 4g of taurine plus 4.8g of sodium butyrate will be administered orally after enrolment on the day before surgery, and then daily thereafter for three months after surgery.

Dietary Supplement: Butyrate and Taurine

Placebo control

PLACEBO COMPARATOR

Placebo group: indistinguishable placebo capsules will be administered orally after enrolment on the day before surgery, followed by daily administration for three months after surgery. Both taurine, butyrate and the indistinguishable placebo capsules are white in color.

Other: Placebo

Interventions

Butyrate and Taurine DIETARY_SUPPLEMENT

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.

butyrate/taurine group

Placebo OTHER

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

Placebo control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Acute Pain; Chronic Pain; Pain, Postoperative

Interventions

Butyrates; Taurine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Henry Wong, MBChB

  Department of Anaesthesia and Intensive Care, The Chinese University of Hong Hong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henry Wong, MBChB

CONTACT

35052734; henrymkwong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients are randomly allocated to combined taurine/butyrate or identical-looking capsules by drawing sequentially numbered, coded, sealed, opaque envelops, each containing the type of intervention assignment or placebo. The sealed envelopes for randomization are prepared by a third party who took no further part in the study. The study investigators, the primary care team and the participants are masked to the group assignments. This is achieved by using an indistinguishable placebo (a proprietary product from Colorcon called StarCap - a mixture of Pregelatinized Maize Starch and Maize Starch) capsules manufactured by an independent pharmaceutical company in Western Australia.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: double-blinded, randomized, placebo-controlled trial

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Within 5 years upon completion of the study
• Access Criteria: The principal investigator of the study has to be informed for access right of the study information

Locations

HK (1)