P-133 PROSPECTIVE INTERVENTIONAL STUDY OF THE ANALGESIC EFFICACY OF A CYCLOMESH™ PARIETAL REINFORCEMENT IMPLANT SOAKED IN ROPIVACAINE HYDROCHLORIDE 10MG/ML IN THE TREATMENT FOR UNCOMPLICATED INGUINAL HERNIA
| Autor: | N Siembida, H Ralaihova, S Moulin, F Aubert, R Boulkedid, O Zourabichvili, J M Regimbeau |
|---|---|
| Rok vydání: | 2022 |
| Předmět: | |
| Zdroj: | British Journal of Surgery. 109 |
| ISSN: | 1365-2168 0007-1323 |
| Popis: | Background 20–30% of patients operated for inguinal hernia will present early postoperative pain (EPP) which is, after the organizational causes, the first cause of conversion from ambulatory to traditional hospitalization. The objective of this study was to evaluate the interest of a parietal prosthesis (Cyclomesh ™) soaked with ropivacaine in the management of EPP. Materials and Methods This is a randomized, phase III, comparative superiority, double-blind, international multicentre study. From October 2019 to February 2022, 290 patients underwent surgery for inguinal hernia with placement of a ropivacaine or saline soaked parietal prosthesis. The primary endpoint was the H6 coughing pain assessment (EVA). Results The intention to treat population (ITTp) was composed of 150 patients in the ropivacaine group and 140 in the placebo group, for the per-protocol population (PPp) it was 125 and 115. The prosthesis type had no significant effect on H6 coughing pain, either for the ITTp (3.3 vs 3.2, p=0.12) or the PPp (3.3 vs 3.7, p=0.15). The ropivaciane soaked prosthesis resulted in a decrease in the overall pain at H2 (2.3 vs 3.2, p Conclusion The placement of a parietal prosthesis (Cyclomesh ™) soaked with ropivacaine did not reduce the H6 coughing pain but allowed a decrease in the overall pain over the first 6 hours after surgery and could simplify the management of patients. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|