Effect of Levobupivacaine Infiltration on the Post Partum Perineal Pain in Episiotomy, in Primiparous Women After Instrumental Delivery

Study Overview
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Brief Summary
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An episiotomy is an incision of the perineum to facilitate childbirth by natural means. Perineal pain are more frequent and intense if the incision of the perineum is important. In particular, simple vaginal or perineal tears are less painful than episiotomies in the first seven days postpartum, whereas at six weeks postpartum, there is no significant difference anymore.The patients are the most symptomatic in the immediate postnatal period, but the pain may persist up to 2 weeks after delivery in 20 to 25% of cases. These pains are often undervalued and may interfere with the mother-child bond in the absence of an effective treatment. Perineal pain are usually treated with painkillers, in particular non-steroidal anti-inflammatory drugs given orally or rectally and paracetamol. The scar infiltration is one of the components of a multimodal postoperative analgesia strategy. It consists in the simultaneous use of several drugs or analgesic techniques, acting on different pain components in order to improve the overall efficiency.The most used local anesthetics at present are bupivacaine, ropivacaine and levobupivacaine.Ropivacaine has a lesser vasodilatory effect than bupivacaine, resulting in longer persistence at the injection point and a blood resorption that is more spread. The systemic toxicity threshold is also higher. Levobupivacaine is the enantiomer of bupivacaine. It has vascular effects, and an intermediate systemic toxicity threshold intermediate between bupivacaine and ropivacaine. Lidocaine has a limited duration of action. Its use is interesting in complement infiltrations when a rapid onset of action is desired. So far, there is no data in the literature regarding the effect of levobupivacaine in episiotomies associated pain. The objective of this study is to evaluate the effect of local injections of levobupivacaine on episiotomies associated pain.

Detailed Description
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An episiotomy is an incision of the perineum to facilitate childbirth by natural means. This gesture is performed in 68% of primiparous women and 31% of multiparous women, according to Audipog data of 2003, with a downward trend since the 80's. The episiotomy reduces the risk of occurrence of anterior perineal tears, but has no preventive effect on 3rd and 4th grade perineal tears, according to the Anglo-Saxon classification. The French national college of obstetricians and gynecologists (CNGOF) recommends thus a restrictive use of episiotomy. Perineal pain are more frequent and intense if the incision of the perineum is important. In particular, simple vaginal or perineal tears are less painful than episiotomies in the first seven days postpartum, whereas at six weeks postpartum, there is no significant difference anymore.The patients are the most symptomatic in the immediate postnatal period, but the pain may persist up to 2 weeks after delivery in 20 to 25% of cases. These pains are often undervalued and may interfere with the mother-child bond in the absence of an effective treatment. Perineal pain are usually treated with painkillers, in particular non-steroidal anti-inflammatory drugs given orally or rectally and paracetamol. The scar infiltration is one of the components of a multimodal postoperative analgesia strategy. It consists in the simultaneous use of several drugs or analgesic techniques, acting on different pain components in order to improve the overall efficiency. This also reduces the consumption of analgesics having multiple side effects, such as opioids. Local anesthetics act at several levels. First, they block the transmission of pain messages at the nocireceptors level and have an analgesic effect on the nearby surgery site. The immediate post-operative pain is thus diminished. Furthermore, by blocking the pain message at the peripheric level, local anesthetics might have an effect on the formation of central hyperalgesia, responsible for longer-term pain. The local anesthetics also have local and systemic anti-inflammatory properties, that may have an effect on postoperative pain and on the establishment of hyperalgesic phenomena. The most used local anesthetics at present are bupivacaine, ropivacaine and levobupivacaine. Ropivacaine has a lesser vasodilatory effect than bupivacaine, resulting in longer persistence at the injection point and a blood resorption that is more spread. The systemic toxicity threshold is also higher. Levobupivacaine is the enantiomer of bupivacaine. It has vascular effects, and an intermediate systemic toxicity threshold intermediate between bupivacaine and ropivacaine. Lidocaine has a limited duration of action. Its use is interesting in complement infiltrations when a rapid onset of action is desired. Many scar infiltration indications are documented in the literature, such as inguinal hernias, hemorrhoids cures, thyroidectomy, orthopedic surgery, breast surgery, and cesarean section.Various studies evaluated the effectiveness of different local anesthetics in episiotomies and perineal tears. So far, there is no data in the literature regarding the effect of levobupivacaine in episiotomies associated pain. The objective of this study is to evaluate the effect of local injections of levobupivacaine on episiotomies associated pain.

Official Title
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Randomized Double Blind Clinical Trial on the Effect of Levobupivacaine Infiltration Versus Placebo on the Post Partum Perineal Pain in Episiotomy in Primiparous Women After Instrumental Delivery

Conditions
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Episiotomy

Intervention / Treatment
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* Drug: Levobupivacaine
* Other: Physiological serum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primiparous Vaginal delivery with instrumentation (Suzor forceps, vacuum extraction, Thierry spatulas) with episiotomy Fœtus In cephalic position Single pregnancy Patient at least 18 years old Term superior or equal to 37 weeks of amenorrhea Patient under epidural analgesia Patient affiliated to a social security scheme Good understanding of French Exclusion Criteria: Ineffective epidural analgesia, defined by the need for additional local anesthesia for episiotomy repair Perineal tear of the 3rd or 4th grade, according to the Anglo-Saxon classification Contra indications to levobupivacaine, paracetamol, ketoprofen Participation refusal Postpartum hemorrhage requiring arterial embolization, reoperation (evacuation of a vaginal thrombus, vessel ligation, hysterectomy by laparotomy) or placement of a Bakri® balloon.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levobupivacaine<br>Primiparous patients in whom a instrumental delivery with episiotomy is conducted. The infiltration of the banks of the episiotomy will be done with Levobupivacaine. This is the only intervention specific to the study, as compared to the standard of care. | Drug: Levobupivacaine<br>* Infiltration of the banks of the episiotomy done with Levobupivacaine<br>|
| Placebo Comparator: Placebo<br>Primiparous patients in whom a instrumental delivery with episiotomy is conducted. The infiltration of the banks of the episiotomy will be done with physiological serum.This is the only intervention specific to the study, as compared to the standard of care. | Other: Physiological serum<br>* Infiltration of the banks of the episiotomy done with physiological serum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ENS pain scale | Pain evaluation on a simple numeric scale (ENS) | 24h post partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Painkillers (ketoprofen) quantity | Cumulated quantity of painkillers taken in addition to paracetamol in the first 48h post partum. Painkillers are given according to standard of care and are not a intervention specific to the study. | During the first 48h post partum | 
| Painkillers (nefopam) quantity | Cumulated quantity of painkillers taken in addition to paracetamol in the first 48h post partum.Painkillers are given according to standard of care and are not a intervention specific to the study. | During the first 48h post partum | 
| Painkillers (ketoprofen) quantity | Quantity of painkillers taken at day 15 post-partum. Painkillers are given according to standard of care and are not a intervention specific to the study. | At day 15 post-partum | 
| Painkillers (nefopam) quantity | Quantity of painkillers taken at day 15 post-partum. Painkillers are given according to standard of care and are not a intervention specific to the study. | At day 15 post-partum | 
| Painkillers (paracetamol) quantity | Quantity of painkillers taken at day 15 post-partum. Painkillers are given according to standard of care and are not a intervention specific to the study. | At day 15 post-partum | 
| ENS pain scale | Pain evaluation on a simple numeric scale (ENS) | At day 15 post-partum | 
| Presence/absence of complications | The quality of cicatrisation of the episiotomy will be assessed in order to track complications. | At day 15 post-partum | 
| Likert scale | Impact of pain secondary to episiotomy on the activities of daily life (sitting, walking, urination, sleep, child care), assessed by the Likert scale | Day 1 post partum | 
| Likert scale | Impact of pain secondary to episiotomy on the activities of daily life (sitting, walking, urination, sleep, child care), assessed by the Likert scale | Day 2 post partum | 
| Likert scale | Impact of pain secondary to episiotomy on the activities of daily life (sitting, walking, urination, sleep, child care), assessed by the Likert scale | Day 15 post partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Episiotomy, Levobupivacaine