Background and Aims Moderate to severe pain is common after cardiac surgery, peaking during the first and second postoperative day. Several nerve blocks for sternotomy have been described, however the optimal location for continuous catheters has not been established. This study sought to assess the feasibility of a larger trial assessing the efficacy of serratus anterior plane (SAP) catheters for sternotomy pain.
Methods This was a double-blinded trial including patients undergoing cardiac surgery via sternotomy. Bilateral SAP catheters were placed in all patients, randomized to Ropivacaine or placebo. Feasibility was assessed based on pre-determined endpoints: 1. Average recruitment rate >4 per month; 2. Protocol adherence rate >90%; 3. Primary outcome measurement rate >90%; 4. Major catheter-related adverse event rate >2%. Quality of recovery index (QoL-15) was compared using an independent t-test.
Results Fifty-two patients were randomized with feasibility data for 50 (2 were withdrawn). There was a poor recruitment rate (2.4 patients per month). There were no major protocol deviations but there were minor deviations in 12% of patients. The primary outcome (QoL-15) was measured in 96% cases. QoL-15 at 72 hours was not different between groups (Ropivacaine 100 +/- 22 vs Placebo 97 +/- 18, p=0.63). The overall incidence of pneumothorax was found to be 12%.
Conclusions A single-center RCT was deemed to be not feasible due to low recruitment rate. It was unclear if the pneumothorax was related to the block since there was not a no-block group. This factor needs to be explored before considering the possibility of a multi-center study.
_REB approval 2021.06
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