Active — Not RecruitingNot 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 range19 Years

SexALL

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

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 completion2026-02-02

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