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Ropivacaine 75?mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women - the ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trials.

ABSTRACT: BACKGROUND:Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. 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?h 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. METHODS/DESIGN: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 (??37?weeks). Perineal infiltration (ropivacaine 75?mg 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?months (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%. DISCUSSION: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. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03084549. Registered on 14 April 2017.

SUBMITTER: Cardaillac C

PROVIDER: S-EPMC7291718 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Ropivacaine 75 mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women - the ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trials.

Cardaillac Claire C Ploteau Stéphane S Le Thuaut Aurélie A Dochez Vincent V Winer Norbert N Ducarme Guillaume G

Trials 20200612 1

<h4>Background</h4>Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. 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 h after birth). Large, adequately powered, multicenter, randomized controlled trials are required ...[more]

PMID: 32532310

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Project description:BackgroundWomen who undergo perineal episiotomy can be affected by several complications such as bleeding, infection, perineal pain, dyspareunia, reduction of sexual desire, as well as urinary and anal incontinence. Perineal pain related to episiotomy has been reported to interfere with women's daily activities postpartum and can prevent proper breastfeeding, proper rooming-in, and maternal-infant bonding. The purpose of this study was to determine the effect of dry heat application on perineal pain and episiotomy wound Healing among primipara women.MethodA quasi-experimental, two-group, pre-post-test research study was conducted at the postnatal inpatient ward and the outpatient clinic of the El-Shatby Maternity University Hospital in Alexandria. A sample of 100 parturient women was divided into the following two groups at random: dry heat and moist (control) heat. Women in the moist heat group were advised to sit in a basin (tub) of warm water for 10 minutes, while those in the dry heat group were instructed to set an infrared light (230 volts) at a distance of 45 cm from the perineum after 12 hours post episiotomy. Both interventions were applied twice a day for ten consecutive days. They evaluated the severity of their perineal pain at baseline and repeated it on the 5th and 10th days after obtaining the interventions while the episiotomy wound healing was assessed on the 5th and 10th days.ResultsIt was discovered that the dry heat group had a significantly improved episiotomy wound healing as regards perineal redness, edema of the perineal area, ecchymosis, wound discharge, and approximation of wound edges on the 5th (P < 0.001, P < 0.001, P < 0.007, P < 0.003, and P < 0.001, respectively) and 10th day after intervention (P < 0.001, P < 0.001, P < 0.001, P < 0.005, and P < 0.001, respectively) than the moist heat group. The primipara women had significantly lower perineal pain intensity in the dry heat group on the 5th and 10th days after intervention than in the moist heat group (MH P < 0.001 for the dry heat group and MH P = 0.004 for the moist heat group).ConclusionThe application of dry heat promoted episiotomy wound healing among primipara women and reduced their perineal pain during early postpartum days than moist heat.

Project description:Epidural anesthesia is commonly administered as part of balanced anesthesia for perioperative analgesia. The main goal of this randomized clinical trial was to compare the efficacy of two epidural approaches in dogs undergoing surgery for a perineal hernia. A secondary aim was to compare motor blockade. Intact ASA 1 and 2 male dogs, weighing ≤25 kg with no previous surgery for perineal hernia were enrolled. After premedication with IM acepromazine 0.02 mg/kg and butorphanol 0.3 mg/kg, general anesthesia was induced with propofol and maintained with sevoflurane in oxygen. Dogs were randomly allocated to receive either a lumbosacral (LS, n = 30) or a sacrococcygeal (SC, n = 26) epidural injection with ropivacaine 1% (0.2 mL/kg) under computed tomography guidance. Successful analgesia was defined as no need of intraoperative rescue analgesia (fentanyl 3 μg/kg IV). Clinical failure was defined as the need of more than two boluses of fentanyl/h each dog received meloxicam 0.2 mg/kg IV at the end of the surgery. The Glasgow Composite Pain Scale short form (GCPS-SF), tactile sensitivity, pressure pain thresholds and motor blockade were assessed at 4, 6, 8, and 24 h after the epidural injection. Methadone (0.2 mg/kg, IV) was administered if the GCPS-SF was ≥6/24 points. Differences between groups were analyzed with the Mann-Whitney U test, Student's t-test or Fisher's Exact test, as appropriate. Success rate was assessed for non-inferiority between groups. The non-inferiority margin was set at -10%. Epidural analgesia was successful in 24 dogs in group LS and 17 dogs in group SC (p = 0.243), resulting in success rates of 80 and 65% in LS and SC groups, respectively. The non-inferiority of group SC versus group LS was confirmed. Clinical failure was recorded in two dogs in group LS and one dog in group SC. No significant differences between groups were detected in the GCPS-SF score, tactile sensitivity, pressure pain thresholds, need of post-operative methadone, or motor blockade. Both epidural techniques are valuable analgesic options for perineal hernia repair in dogs.

Project description:OBJECTIVE:To evaluate the reduction of perineal pain after vaginal deliveries by capacitive resistive radiofrequency therapy (RF). METHODS:We conducted a double-blind randomized study in University Hospital Centre in France. We included women presenting either perineal tears or an episiotomy after vaginal delivery (instrumental assisted or not). The participants were randomly assigned to RF or not at day 1 and day 2 postpartum. The primary outcome was pain evaluated as visual analog scale (VAS) score >4 at rest on day 2 after the treatment. Secondary outcomes included discomfort and pain while walking and seating two days after treatment, type of pain two days after treatment and analgesics intake two days after treatment, sexual intercourse retake and painful of intercourse were also assessed by phone call 30 days after delivery. We performed univariate analysis and multivariable regressions adjusting on the value of the outcome at baseline to improve precision of the estimated intervention effect. RESULTS:Between June 1, 2017 and October 8, 2017, the RF group included 29 women compared with 31 women in the group without RF. There was no significant difference on VAS >4 between the two groups (13.8% vs. 9.7% p = 0.69; difference = 4.1%, 95%CI -12.2%- 20.4%); consumption of paracetamol was lower in the RF group (978.3 mg (sd = 804.5) vs 1703.7 mg (sd = 1381.6), p = 0.035; difference = -725.3 mg, 95%CI -1359.6 - -91.3). Multivariate analysis showed no association between RF and pain. Nevertheless, we found an association between RF and discomfort while walking (adjusted OR 0.24, 95% CI 0.07-0.90; p = 0.03). CONCLUSION:VAS>4 at day 2 was not different in the experimental and the control groups but RF was associated with less perineal discomfort while walking and lower consumption of paracetamol after delivery. CLINICAL TRIAL REGISTRATIONS:The study was registered in the Clinical Government trial (https://clinicaltrials.gov/ct2/show/NCT03172286?term=bretelle&rank=2) under the number NCT03172286.

Dataset Information

Ropivacaine 75?mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women - the ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trials.

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Ropivacaine 75 mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women - the ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trials.

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