Continuous Serratus Anterior Blockade for Sternotomy
- Conditions
- Opioid UseQuality of LifePostoperative Pain
- Interventions
- Procedure: Serratus anterior plane (SAP) blockProcedure: Normal saline placebo
- Registration Number
- NCT04648774
- Lead Sponsor
- Nova Scotia Health Authority
- 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.
- 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%.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Adult (aged >18 years) patients at time of screening
- Undergoing valvular replacement/repair and/or coronary artery bypass grafting (CABG)
- via median sternotomy
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active serratus anterior plane (SAP) block with Ropivacaine 0.2% Serratus anterior plane (SAP) block - Placebo serratus anterior plane (SAP) block with normal saline Normal saline placebo -
- Primary Outcome Measures
Name Time Method Adherence rate 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) 72 hours The number of patients completing the quality of recovery 15 (QoR-15) index
Recruitment rate 1 month Number of patients recruited to the study
Combined major block-related adverse event rate 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.
- Secondary Outcome Measures
Name Time Method Opioid use 24, 48, 72 hours Measured by oral morphine equivalents (OME) in milligrams
Quality of recovery 15 index (QoR-15) 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).
Pain scores 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.
Trial Locations
- Locations (1)
Nova Scotia Health Authority
🇨🇦Halifax, Nova Scotia, Canada