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Study protocol
Ropivacaine 75mg 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 trial.
Guillaume Ducarme
Centre Hospitalier Departemental
Corresponding Author
ORCiD: https://orcid.org/0000-0002-2549-353X
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This work is licensed under a CC BY 4.0 License. Read Full License
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 already investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours 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 The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial 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 75mg 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 (mid-term), defined by the numerical rating scale of pain (ENS NRS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS NRS), 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 sexuality (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, easy to administer, and 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.
Keywords
Perineal pain, Episiotomy, Ropivacaine, Local infiltration
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On 30 Apr, 2020
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Received 29 Apr, 2020
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On 20 Apr, 2020
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Received 21 Feb, 2020
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On 19 Feb, 2020
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Editor assigned
On 19 Feb, 2020
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Review #2 received
Received 23 Jan, 2020
Editorial decision: Minor revision
On 23 Jan, 2020
Reviewer #2 agreed
On 21 Jan, 2020
Review #1 received
Received 18 Jan, 2020
Reviewers invited
Invitations sent on 07 Jan, 2020
Reviewer #1 agreed
On 07 Jan, 2020
Editor assigned
On 10 Oct, 2019
Submission checks complete
On 09 Oct, 2019
No comments provided
Editorial decision: Minor revision
On 10 Sep, 2019
Editor assigned
On 06 Sep, 2019
Submission checks complete
On 26 Jun, 2019
First submitted
On 14 Jun, 2019
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Ropivacaine 75mg 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 trial.
Guillaume Ducarme
Centre Hospitalier Departemental
Corresponding Author
ORCiD: https://orcid.org/0000-0002-2549-353X
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 4
Posted 26 May, 2020
No community comments so far
Editor assigned
On 14 May, 2020
Submission checks complete
On 13 May, 2020
No comments provided
Editorial decision: Minor revision
On 30 Apr, 2020
Review #2 received
Received 29 Apr, 2020
Reviewer #2 agreed
On 20 Apr, 2020
Review #1 received
Received 21 Feb, 2020
Reviewer #1 agreed
On 19 Feb, 2020
Reviewers invited
Invitations sent on 19 Feb, 2020
Editor assigned
On 19 Feb, 2020
Submission checks complete
On 18 Feb, 2020
No comments provided
Review #2 received
Received 23 Jan, 2020
Editorial decision: Minor revision
On 23 Jan, 2020
Reviewer #2 agreed
On 21 Jan, 2020
Review #1 received
Received 18 Jan, 2020
Reviewers invited
Invitations sent on 07 Jan, 2020
Reviewer #1 agreed
On 07 Jan, 2020
Editor assigned
On 10 Oct, 2019
Submission checks complete
On 09 Oct, 2019
No comments provided
Editorial decision: Minor revision
On 10 Sep, 2019
Editor assigned
On 06 Sep, 2019
Submission checks complete
On 26 Jun, 2019
First submitted
On 14 Jun, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
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 already investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours 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 The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial 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 75mg 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 (mid-term), defined by the numerical rating scale of pain (ENS NRS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS NRS), 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 sexuality (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, easy to administer, and 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.
Figure 1