Postoperative PainCardiac-SAPNCT04648774
Continuous Serratus Anterior Blockade for Sternotomy
A study testing Serratus anterior plane (SAP) block in people with Postoperative Pain and Opioid Use, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Postoperative Pain, Opioid Use, Quality of Life
- What is being tested?
- Serratus anterior plane (SAP) block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jul 2021to 2 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (aged >18 years) patients at time of screening
- Undergoing valvular replacement/repair and/or coronary artery bypass grafting (CABG)
- via median sternotomy
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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%.
- Conditions
- Postoperative Pain, Opioid Use, Quality of Life
- Being tested
- Serratus anterior plane (SAP) block, Normal saline placebo
- Keywords
- cardiac surgery, regional anesthesia, fascial plane block, enhanced recovery after surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus anterior plane (SAP) blockProcedure or surgery
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.
Normal saline placeboProcedure or surgery
Patients in both groups will receive the standard of care analgesic medications in the cardiovascular intensive care unit and the ward.
| Study group | Role | What they receive |
|---|---|---|
| Active serratus anterior plane (SAP) block with Ropivacaine 0.2% | Active comparator | Not described Receives: Procedure: Serratus anterior plane (SAP) block |
| Placebo serratus anterior plane (SAP) block with normal saline | Placebo comparator | Not described Receives: Procedure: Normal saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of patients recruited to the study
Measured: 1 month
Adherence rate
The number of patients with no protocol violations
Measured: 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
Measured: 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.
Measured: Until block catheter is removed at 72 hours
Secondary outcomes (3)
Quality of recovery 15 index (QoR-15)
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).
Measured: 48, 72 hours
Pain scores
Measured by numeric rating scale (NRS). The NRS has possible scores from 0 to 10 with higher numbers indicating worse pain.
Measured: 24, 48, 72 hours
Opioid use
Measured by oral morphine equivalents (OME) in milligrams
Measured: 24, 48, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start22 Jul 2021
- Primary completion2 Feb 2023
- Study completion2 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A computer-generated random number will be assigned and tracked by the central pharmacy to randomize patients on a 1:1 basis to the Ropivacaine and placebo groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648774
- Sponsor's protocol ID
- NSH REB#1026626
- Acronym
- Cardiac-SAP
- Status last verified
- Jun 2026
- First submitted
- 24 Nov 2020
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39863465
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Serratus Anterior Blockade for Sternotomy Analgesia Following Cardiac Surgery: A Pilot Feasibility Study.
- ClinicalTrials.gov ID
- NCT04648774
- Acronym / sponsor ID
- Cardiac-SAP / NSH REB#1026626
- Conditions
- Postoperative Pain, Opioid Use, Quality of Life
- Keywords
- cardiac surgery, regional anesthesia, fascial plane block, enhanced recovery after surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A computer-generated random number will be assigned and tracked by the central pharmacy to randomize patients on a 1:1 basis to the Ropivacaine and placebo groups.
| Arm | Type | Receives |
|---|---|---|
| Active serratus anterior plane (SAP) block with Ropivacaine 0.2% | Active comparator | Procedure: Serratus anterior plane (SAP) block |
| Placebo serratus anterior plane (SAP) block with normal saline | Placebo comparator | Procedure: Normal saline placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (aged >18 years) patients at time of screening
- Undergoing valvular replacement/repair and/or coronary artery bypass grafting (CABG)
- via median sternotomy
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serratus anterior plane (SAP) blockWith 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. | Procedure or surgery | Active serratus anterior plane (SAP) block with Ropivacaine 0.2% |
| Normal saline placeboPatients in both groups will receive the standard of care analgesic medications in the cardiovascular intensive care unit and the ward. | Procedure or surgery | Placebo serratus anterior plane (SAP) block with normal saline |
Primary outcome
Recruitment rate
Time frame: 1 month
Number of patients recruited to the study
Adherence rate
Time frame: Until measurement of quality of recovery at 72 hours
The number of patients with no protocol violations
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
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.
3 secondary outcomes
Quality of recovery 15 index (QoR-15)
Time frame: 48, 72 hours
Pain scores
Time frame: 24, 48, 72 hours
Opioid use
Time frame: 24, 48, 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Derived from this study: PubMed 39863465Bailey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus anterior plane (SAP) block in people with Postoperative Pain and Opioid Use, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04648774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.