Continuous Serratus Anterior Blockade for Sternotomy
Cardiac-SAP
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable postoperative-pain
Started Jul 2021
Longer than P75 for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2020
CompletedFirst Posted
Study publicly available on registry
December 2, 2020
CompletedStudy Start
First participant enrolled
July 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
ExpectedAugust 23, 2024
August 1, 2024
4.5 years
November 24, 2020
August 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Recruitment rate
Number of patients recruited to the study
1 month
Adherence rate
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)
The number of patients completing the quality of recovery 15 (QoR-15) index
72 hours
Combined major block-related adverse event rate
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 Outcomes (3)
Quality of recovery 15 index (QoR-15)
48, 72 hours
Pain scores
24, 48, 72 hours
Opioid use
24, 48, 72 hours
Study Arms (2)
Active serratus anterior plane (SAP) block with Ropivacaine 0.2%
ACTIVE COMPARATORPlacebo serratus anterior plane (SAP) block with normal saline
PLACEBO COMPARATORInterventions
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.
Patients in both groups will receive the standard of care analgesic medications in the cardiovascular intensive care unit and the ward.
Eligibility Criteria
You may qualify if:
- Adult (aged \>18 years) patients at time of screening
- Undergoing valvular replacement/repair and/or coronary artery bypass grafting (CABG)
- via median sternotomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nova Scotia Health Authority
Halifax, Nova Scotia, B3S 0H6, Canada
Related Publications (1)
Bailey JG, Hendy A, Neira V, Chedrawy E, Uppal V. Continuous serratus anterior block for sternotomy analgesia after cardiac surgery: a single-centre feasibility study. Br J Anaesth. 2025 Apr;134(4):1161-1169. doi: 10.1016/j.bja.2024.11.042. Epub 2025 Jan 24.
PMID: 39863465DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The Nova Scotia Health (NSH) pharmacy will prepare either Ropivacaine 0.2% (2mg/ml) or normal saline in identical bags labelled as "study drug" such that the patient, clinical staff and the researchers are blinded to assigned group. The pharmacy will maintain the assignment list, only unmasking assignment in cases of suspected local anesthetic systemic toxicity (LAST) or allergic reactions.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2020
First Posted
December 2, 2020
Study Start
July 22, 2021
Primary Completion
February 2, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
August 23, 2024
Record last verified: 2024-08