Novel temperature-responsive hydrogel injected to the incision site for postoperative pain relief in laparoscopic abdominal surgery: a single-blind, randomized, pivotal clinical trial.

Abstract

A temperature-responsive hydrogel (PF-72; TGel Bio, Inc., Ltd, Seoul, Korea), developed as a sustained drug delivery device, can be mixed with ropivacaine to reduce pain in the incision area. The hydrogel is soluble at low temperatures (2-8°C) and is converted into a gel at high temperatures (> 30°C). We aimed to evaluate whether the administration of ropivacaine using PF-72 at incision sites reduces pain until 72h postoperatively in patients undergoing laparoscopic stomach or colorectal surgery. Patients were randomly assigned to the control group (0.75% ropivacaine) or PF-72 group (PF-72 mixed with 0.75% ropivacaine). Before surgical incision closure, 0.75% ropivacaine or PF-72 mixed with 0.75% ropivacaine was injected into the subcutaneous fat and muscle of all incisions. Postoperative pain was evaluated by the Numerical Rating Scale (NRS, 0 = no pain, 10 = most severe pain) for wound pain at 3, 6, 24, 48, and 72h after the end of surgery. Ninety-nine patients (control, n = 51; PF-72, n = 48) were included in the analysis. The areas under the curve of NRS for wound pain until 72h in the control group and the PF-72 group were 188.7 ± 46.1 and 135.3 ± 49.9h, respectively (P < 0.001). The frequency of the administration of rescue analgesics in the general ward was similar between the two groups. PF-72 mixed with 0.75% ropivacaine reduced postoperative pain until 72h in patients undergoing laparoscopic surgery. Although the study population was not large enough for safety evaluation, no adverse events associated with PF-72 were observed.