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

ConditionsCoronary Artery Bypass Graft (CABG)Chest TubesPost Operative Pain Control
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Calgary

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 0.5% Bupivacaine without epinephrine

    Drug

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

  • 10cc injection of normal saline (0.9%)

    Drug

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: 0.9% Saline (Placebo)Placebo comparator 1 intervention
Group B: 0.5% Bupivacaine group (intervention)Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
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

1

Cumulative postoperative opioid analgesic and NSAID consumption in postoperative period

Mean total doses of opioid analgesics and NSAIDs administered postoperatively

Time frame
From extubation in the CVICU until discharge from the cardiovascular intensive care unit (CVICU), up to 7 days postoperatively.
2

Length of hospital stay

Length of stay in the intensive care unit (ICU) and total hospital length of stay

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: