Chest Tube-Delivered Bupivacaine to Decrease Postoperative Pain After Cardiac Surgery

NCT07643506 | Not Yet Recruiting Early Phase 1

• 1 other identifier: REB26-0191
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: After heart surgery, patients require temporary chest tubes - plastic drains placed inside the chest to prevent fluid building up around the heart and lungs. These tubes are often very painful and can limit breathing, coughing, and movement, which necessitates usage of painkiller medication (opioids and non-steroidal anti-inflammatory drugs (NSAIDs)) that have negative side effects and can prolong hospital recovery. Despite this common problem, routine care lacks simple, add-on strategies that directly numb pain at the chest tube sites rather than relying solely on whole-body painkiller medicine. Purpose: To determine whether injecting a long-acting numbing medicine (bupivacaine 0.5%) through chest tubes safely reduces pain and lowers opioid and NSAID use compared with placebo. Objective: With ethics approval, data access, and study procedures already in place before May, the specific objective for this studentship is to collect and analyze data to evaluate the short-term effect of bupivacaine versus placebo on:

• Mean pain scores from initial recovery to chest tube removal
• Total mean opioid and NSAID use Methods: This single-centre, 1:1 block randomized, double-blind, placebo-controlled trial will enroll 60 adults undergoing coronary artery bypass (procedure to bypass blocked blood vessels supplying heart muscle using healthy blood vessels) at the Foothills Medical Centre. Patients receive either 10 mL bupivacaine 0.5% or normal saline (saltwater placebo) through chest tubes by heart surgeons whenever pain hits ≥3/10 using the Numeric Rating Scale (0 = no pain; 10 = most intense pain), from initial recovery to chest tube removal. Standard pain care will continue for all patients. The study team will record pain scores, opioid and NSAID doses, and any side effects for each group. Interval pain reduction will be measured 30, 60, 120 and 240 minutes post injection. Mean pain reduction and total painkiller use will be compared between the two groups.

Conditions

Coronary Artery Bypass Graft (CABG); Chest Tubes; Post Operative Pain Control

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  The primary outcome is pain intensity as measured by a validated numeric rating scale (NRS; 0-10, where 0 = no pain and 10 = most intense pain imaginable) at pre-specified time points in the postoperative period starting from extubation in the CVICU.

  The solution will be administered whenever patients report a pain equal or above 3/10 on the intensity numeric rating scale (NRS) and pain will be measured at 30, 60, 120, and 240 minutes after study solution injection during the postoperative period.

Secondary Outcomes (2)

• Cumulative postoperative opioid analgesic and NSAID consumption in postoperative period

  From extubation in the CVICU until discharge from the cardiovascular intensive care unit (CVICU), up to 7 days postoperatively.

• Length of hospital stay

  From hospital admission until CVICU discharge and from hospital admission until hospital discharge, respectively (up to 30 days postoperatively).

Study Arms (2)

0.9% Saline (Placebo)

PLACEBO COMPARATOR

10cc injection of normal saline (0.9%)

Drug: 10cc injection of normal saline (0.9%)

0.5% Bupivacaine group (intervention)

EXPERIMENTAL

10cc injection Bupivacaine 0.5% without epinephrine

Drug: 0.5% Bupivacaine without epinephrine

Interventions

10cc injection of normal saline (0.9%) DRUG

10cc injection of normal saline (0.9%) through pleural chest tubes

0.9% Saline (Placebo)

0.5% Bupivacaine without epinephrine DRUG

Injection of 10cc 0.5% Bupivacaine without epinephrine through pleural chest tubes

0.5% Bupivacaine group (intervention)

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older at the time of consent
• Scheduled to undergo elective or semi-elective coronary artery bypass graft (CABG) surgery via midline sternotomy
• Procedure involves the use of a mammary artery graft
• Capable of providing informed written consent prior to surgery
• Able to communicate pain scores using a numeric rating scale (NRS)
• These criteria ensure the study population is the clinically relevant group most likely to benefit from the intervention and that participants can provide valid consent and meaningful pain assessments.

You may not qualify if:

• Known allergy or hypersensitivity to bupivacaine or any amide-type local anesthetic
• Emergency or urgent cardiac surgery where obtaining consent prior to the procedure is not feasible
• Inability to communicate pain using numeric rating scale due to cognitive impairment, language barrier, or altered level of consciousness
• Participation in another interventional clinical trial that may confound pain outcome

Sponsors & Collaborators

• University of Calgary: lead

MeSH Terms

Interventions

Bupivacaine; Epinephrine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Corey Adams, MD

CONTACT

403-944-6557; corey.adams@albertahealthservices.ca

Brandon Pentz, MSc

CONTACT

Brandon.Pentz@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group will receive the bupivicaine while another group will receive placebo

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 11, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-06