CompletedNot Applicable

Continuous Serratus Anterior Blockade for Sternotomy

Canada50 participantsStarted 2021-07-22

Plain-language summary

This is a pilot study to assess the feasibility of a full study. The purpose is to assess the analgesic effectiveness of the serratus anterior plane (SAP) block following cardiac surgery. Patients will be randomized to receive either Ropivacaine 0.2% or placebo via bilateral SAP block catheters for 72 hours postoperatively.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult (aged \>18 years) patients at time of screening * Undergoing valvular replacement/repair and/or coronary artery bypass grafting (CABG) * via median sternotomy Exclusion Criteria: * Surgery on an emergency basis (level 1 or 2, \<2 hours) * An ejection fraction \<30% * Patient on extracorporeal membrane oxygenator (ECMO), * Presence of an intra-aortic balloon pump (IABP) * Preoperative vasopressors or inotropes * Severe pre-existing liver disease (Child B or C) * Severe kidney disease (Glomerular filtration rate (GFR) \<30 (mL/min/1·73m²)) * An allergy to ropivacaine * Planned circulatory arrest * BMI \>35 * Weight \<50 kg * Opioid tolerant (oral morphine equivalent \>60mg per day for \>1 week prior to admission) * Unable to provide valid consent to study prior to surgery

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recruitment rate

Timeframe: 1 month

Adherence rate

Timeframe: Until measurement of quality of recovery at 72 hours

Primary outcome measurement rate (quality of recovery 15 index)

Timeframe: 72 hours

Combined major block-related adverse event rate

Timeframe: Until block catheter is removed at 72 hours

Trial details

NCT IDNCT04648774

SponsorNova Scotia Health Authority

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-02

View on ClinicalTrials.gov More Postoperative Pain trials