The efficacy of elastomeric patient-control module when connected to a balloon pump for postoperative epidural analgesia: A randomized, noninferiority trial

When considering the principles of a pain control strategy by patients, reliable administration of additional bolus doses is important for providing the adequate analgesia and improving patient satisfaction. We compared the efficacy of elastomeric patient-control module (PCM) with conventional PCM providing epidural analgesia postoperatively. A noninferiority comparison was used. Eighty-six patients scheduled for open upper abdominal surgery were randomized to use either an elastomeric or conventional PCM connected to balloon pump. After successful epidural catheter insertion at T(6–8) level, fentanyl (15–20 μg/kg) in 0.3% ropivacaine 100 mL was administered at basal rate 2 mL/h with bolus 2 mL and lock-out time 15 minutes. The primary outcome was the verbal numerical rating score for pain. The 95% confidence intervals for differences in pain scores during the first 48 hours postoperatively were <1, indicating noninferiority of the elastomeric PCM. The duration of pump reservoir exhaustion was shorter for the elastomeric PCM (mean [SD], 33 hours [8 hours] vs 40 hours [8 hours], P = 0.0003). There were no differences in the frequency of PCM use, additional analgesics, or adverse events between groups. The elastomeric PCM was as effective as conventional PCM with and exhibited a similar safety profile.