Efficacy of CycloMesh™+Ropivacaine in the treatment of uncomplicated inguinal hernia after the Lichtenstein procedure: Results of a prospective multicentric double-blind study.

Abstract

Background: Twenty to 30% of patients undergoing inguinal hernia surgery (20 million patients per year worldwide) present early postoperative pain. The aim of this study was to assess the interest of a mesh (CycloMesh™, Cousin Biotech) soaked with ropivacaine for managing early postoperative pain.

Materials and methods: This was a randomized, phase III, comparative superiority, double-blind, international multicenter study. From October 2019 to February 2022, 290 patients underwent surgery for uncomplicated inguinal hernia, under general anesthesia, using the Liechtenstein technique. Each patient was randomly assigned to either the experimental group (mesh soaked in ropivacaine hydrochloride 10mg/mL) or the control group (mesh soaked in physiological saline solution). The primary endpoint was the pain at cough assessment with the visual analogue scale (VAS) at H6 after the surgery. The secondary endpoints were the global pain assessment at H2, H4, H6, day 1, day 2, day 3, day 7, 1month, 1year, and 2years after the surgery, assessment of antalgic consumption, description of the surgical procedure and postoperative complications rate, hospitalization and post-hospital discharge data (number of conversions from outpatient to inpatient care), and recurrence.

Results: Of the 290 patients included in the study, 150 and 140 patients were in the experimental or control group respectively. The per-protocol (PP) population (240 patients) comprised 125 patients in the ropivacaine group and 115 in the control group. The mesh soaking solution had no significant effect on the pain at cough at H6, either in the intention-to-treat population (3.3 vs 3.2, P=0.12) or in the PP population (3.3 vs 3.7, P=0.15). The ropivacaine-soaked prosthesis resulted in a reduction in overall pain at H2 (2.3 vs 3.2, P<0.0001), H4 (2.3 vs 3.1, P<0.0001) and H6 (2.3 vs 2.7, P=0.0039). There was no difference between the two groups in terms of antalgic consumption, postoperative complications, or the number of ambulatory conversions.

Conclusion: The placement of CycloMesh™ soaked with ropivacaine did not reduce the pain at cough at H6 but did reduce overall pain in the first 6hours after surgery and could simplify patient management.