Randomized Trial of Poloxamer 407-Based Ropivacaine Hydrogel After Thoracoscopic Pulmonary Resection

Abstract

Background: We conducted a comparative study to evaluate the efficacy of poloxamer 407-based ropivacaine hydrogel at the wound site (Gel) and continuous thoracic paravertebral block using On-Q PainBuster (On-Q; B. Braun Medical) for postoperative pain after thoracoscopic pulmonary resection.

Methods: This prospective, randomized, noninferiority study included 89 patients randomized to the Gel group (poloxamer 407-based 0.75% ropivacaine, 22.5 mg) or the On-Q group (0.2% ropivacaine, 4 mg/h for 48 hours). The primary outcome measure was total fentanyl consumption, and secondary outcome measures were the need for rescue analgesia and pain intensity using the numeric rating scale (NRS).

Results: There was no significant difference in total fentanyl consumption between the Gel group and the On-Q group (1504.29 ± 315.72 μg vs 1560.32 ± 274.81 μg, P = .374). Pain intensity using the NRS between the Gel group and the On-Q group demonstrated no statistical differences at 6 hours (3.56 vs 3.55, P = .958), 24 hours (3.21 vs 3.00, P = .25), 48 hours (2.75 vs 2.49, P = .233), and 72 hours (2.39 vs 2.33, P = .811), and there was no significant difference in the frequency of analgesic rescue medication use (3.70 vs 3.33, P = .417).

Conclusions: We confirm the noninferiority of Gel compared with On-Q for acute postoperative pain after thoracoscopic pulmonary resection. Considering a technical simplicity and low systemic toxicity of the local injection of Gel, this analgesic modality may be worthy of further research and is thus considered to have potential as a viable alternative to On-Q for regional analgesia.