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Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy but have only focused on the immediate postpartum period (at 24 and 48\u2009h after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and mid- and long-term quality of life before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods\/design<\/jats:title>\n                    <jats:p>The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial being conducted in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (\u2265\u200937\u2009weeks). Perineal infiltration (ropivacaine 75\u2009mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (midterm), defined by the Numeric Pain Rating Scale (NPRS) strictly superior to 3\/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (NPRS) and the impact of pain on daily behavior, on the quality of life (36-item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale), and on sexual health (Female Sexual Function Index) at 3 and 6\u2009months (long-term) using validated online questionnaires. This study will have 90% power to show approximately 30% relative risk reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>Ropivacaine is a promising candidate drug, inexpensive, and easy to administer, and it would be suitable to include in the routine management of deliveries in labor ward. This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov,\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03084549?term=ROPISIO\">NCT03084549<\/jats:ext-link>\n                      . Registered on 14 April 2017.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-020-04423-x","type":"journal-article","created":{"date-parts":[[2020,6,12]],"date-time":"2020-06-12T05:04:12Z","timestamp":1591938252000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Ropivacaine 75\u2009mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women \u2013 the ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trials"],"prefix":"10.1186","volume":"21","author":[{"given":"Claire","family":"Cardaillac","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"St\u00e9phane","family":"Ploteau","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aur\u00e9lie","family":"Le Thuaut","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vincent","family":"Dochez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Norbert","family":"Winer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2549-353X","authenticated-orcid":false,"given":"Guillaume","family":"Ducarme","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,6,12]]},"reference":[{"key":"4423_CR1","doi-asserted-by":"publisher","first-page":"CD000947","DOI":"10.1002\/14651858.CD000947.pub2","volume":"4","author":"C Kettle","year":"2007","unstructured":"Kettle C, Hills RK, Ismail KM. 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N Engl J Med. 1997;336:309\u201315.","journal-title":"N Engl J Med"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-020-04423-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-020-04423-x\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-020-04423-x.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,6,11]],"date-time":"2021-06-11T19:33:16Z","timestamp":1623439996000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-020-04423-x"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,6,12]]},"references-count":45,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,12]]}},"alternative-id":["4423"],"URL":"https:\/\/doi.org\/10.1186\/s13063-020-04423-x","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.2.10758\/v3","asserted-by":"object"},{"id-type":"doi","id":"10.21203\/rs.2.10758\/v4","asserted-by":"object"},{"id-type":"doi","id":"10.21203\/rs.2.10758\/v1","asserted-by":"object"},{"id-type":"doi","id":"10.21203\/rs.2.10758\/v2","asserted-by":"object"}]},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,6,12]]},"assertion":[{"value":"14 June 2019","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"16 May 2020","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 June 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"All participants will be told about the study, and written information will be given by the attending physician or midwife during the eighth month. Written consent will be obtained by the medical team in charge of the study before inclusion (attending physician or midwife). The study protocol and this consent procedure were approved by the Angers Committee Ouest II for the Protection of Research Subjects (Ethics Committee) on 17 January 2017 (EudraCT 2016-002786-62) and by the ANSM on 14 April 2017 (17-0057A-32). All participants will undergo the informed consent process using institutional review board\u2013approved consent documents. The ROPISO trial was sponsored by the La Roche sur Yon Hospital. This trial was registered with clinicaltrials.gov (NCT03084549) on 14 April 2017 and includes all items from the World Health Organization (WHO) Trial Registration Data Set (\n                      \n                      ) [\n                      \n                      ].","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"522"}}