Continuous Serratus Anterior Blockade for Sternotomy (Cardiac-SAP)

June 1, 2026 updated by: Nova Scotia Health Authority

Continuous Serratus Anterior Blockade for Sternotomy Analgesia Following Cardiac Surgery: A Pilot Feasibility Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inadequate pain relief following cardiac surgery increases morbidity, length of stay in the intensive care unit, persistent pain, and costs. Moderate to severe pain is common after cardiac surgery, peaking during the first and second postoperative day, then decreasing after the third day.

Regional anesthesia as part of a multimodal pain management strategy has become a key feature of cardiac surgery enhanced recovery after surgery (ERAS) protocols. A technique consolidating the pectoralis nerve block (PECS) and serratus anterior plane block (SAPB) into a single injection has been described, also called the serratus anterior plane (SAP) block. Given the relative paucity of evidence assessing the utility of continuous serratus anterior plane block (cSAP) in cardiac surgery, we decided to assess the feasibility of a placebo controlled randomized controlled trial (RCT) with a pilot study.

Primary Pilot Study Objective To assess feasibility of a larger intervention study by measuring recruitment rate, adherence rate, retention rates and continuous serratus anterior plane block (cSAP)-related adverse events following cardiac surgery via median sternotomy.

Methods This study will include patients undergoing valvular replacement/repair and/or coronary artery bypass grafting (CABG) at the QEII Health Sciences Center in Halifax, Nova Scotia. The study will include a maximum of 50 participants, randomly assigned to 2 study arms of 25 participants. A computer-generated random number will be assigned by the central pharmacy to randomize patients on a 1:1 basis to the Ropivacaine and placebo groups.

cSAP block procedure - Study Intervention A member of the cardiac anesthesia or regional anesthesia team will place bilateral serratus anterior catheters under ultrasound guidance within 2 hours of arrival to the cardiovascular intensive care unit. A bolus of study drug 20ml (either ropivacaine 0.2% or normal saline) will be delivered at the time of the block. A 18g multiholed catheter will be inserted and secured to the patients' skin. The same procedure will be followed on the contralateral side. The study drug will be administered by programmed intermittent bolus (PIB) 10ml every 2 hours to each side in a staggered, alternating fashion. The PIB study drug will to be continued for 72 hours post-insertion.

Feasibility endpoints The study will be deemed feasible if it meets the following predetermined endpoints: 1. Recruitment of 4 patients per month; 2. The adherence rate to protocols is >90%; 3. Primary outcome measurement rate is >90%; 4. Combined major catheter-related adverse event rate (pneumothorax + LAST + allergic reaction) is <2%.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3S 0H6
        • Nova Scotia Health Authority

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active serratus anterior plane (SAP) block with Ropivacaine 0.2%
Procedure: Serratus anterior plane (SAP) block
With the patient in supine position, an ultrasound transducer will be used to find the 4th rib in the mid-axillary line. A 17g touhy needle will be introduced in-plane in an inferior to superior direction until its tip rests between the serratus anterior muscle and the 4th rib or the 3rd external intercostal muscle. A bolus of study drug 10ml (either ropivacaine 0.2% or normal saline) will be delivered though the needle. A 18g multiholed catheter will be inserted and secured to the patients' skin with adhesive dressings. A further 10ml of study drug will be administered through the catheter. The same procedure will be followed on the contralateral side. The study drug will be administered by programmed intermittent bolus (PIB) 10ml every 2 hours to each side in a staggered, alternating fashion. The PIB study drug will to be continued for 72 hours post-insertion.
Placebo Comparator: Placebo serratus anterior plane (SAP) block with normal saline
Procedure: Normal saline placebo
Patients in both groups will receive the standard of care analgesic medications in the cardiovascular intensive care unit and the ward.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 1 month
Number of patients recruited to the study
1 month
Adherence rate
Time Frame: Until measurement of quality of recovery at 72 hours
The number of patients with no protocol violations
Until measurement of quality of recovery at 72 hours
Primary outcome measurement rate (quality of recovery 15 index)
Time Frame: 72 hours
The number of patients completing the quality of recovery 15 (QoR-15) index
72 hours
Combined major block-related adverse event rate
Time Frame: Until block catheter is removed at 72 hours
The number of patients experiencing a major block-related adverse event including pneumothorax, local anesthetic systemic toxicity (LAST) or allergic reaction.
Until block catheter is removed at 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of recovery 15 index (QoR-15)
Time Frame: 48, 72 hours
The quality of recovery (QoR-15) questionnaire includes five domains of recovery after surgery: patient support, comfort, emotions, physical independence, and pain. Each item is graded on an eleven-point Likert scale with QoR-15 scores ranging from 0 (extremely poor quality of recovery) to 150 (excellent quality of recovery).
48, 72 hours
Pain scores
Time Frame: 24, 48, 72 hours
Measured by numeric rating scale (NRS). The NRS has possible scores from 0 to 10 with higher numbers indicating worse pain.
24, 48, 72 hours
Opioid use
Time Frame: 24, 48, 72 hours
Measured by oral morphine equivalents (OME) in milligrams
24, 48, 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2021

Primary Completion (Actual)

February 2, 2023

Study Completion (Actual)

August 2, 2023

Study Registration Dates

First Submitted

November 24, 2020

First Submitted That Met QC Criteria

November 24, 2020

First Posted (Actual)

December 2, 2020

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSH REB#1026626

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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