Continuous Serratus Anterior Blockade for Sternotomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-22

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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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

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Postoperative Pain Opioid Use Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Active serratus anterior plane (SAP) block with Ropivacaine 0.2%

Group Type ACTIVE_COMPARATOR

Serratus anterior plane (SAP) block

Intervention Type PROCEDURE

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 serratus anterior plane (SAP) block with normal saline

Group Type PLACEBO_COMPARATOR

Normal saline placebo

Intervention Type PROCEDURE

Patients in both groups will receive the standard of care analgesic medications in the cardiovascular intensive care unit and the ward.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No