Opioid Use, Postoperative Pain, Quality of Life
Conditions
Keywords
cardiac surgery, regional anesthesia, fascial plane block, enhanced recovery after surgery
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%.
Interventions
PROCEDURESerratus 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.
PROCEDURENormal saline placebo
Patients in both groups will receive the standard of care analgesic medications in the cardiovascular intensive care unit and the ward.
Sponsors
Nova Scotia Health Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 1 month | Number of patients recruited to the study |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Opioid use | 24, 48, 72 hours | Measured by oral morphine equivalents (OME) in milligrams |
Countries
Canada
Outcome results
None listed