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

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ClinicalTrials.gov Identifier: NCT02796547
Recruitment Status : Withdrawn (Lack of human ressources)
First Posted : June 10, 2016
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Andre Nazac, Brugmann University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Episiotomy Drug: Levobupivacaine Other: Physiological serum Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 14, 2016
Actual Primary Completion Date : May 29, 2018
Actual Study Completion Date : May 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Arm Intervention/treatment
Experimental: Levobupivacaine
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
Infiltration of the banks of the episiotomy done with Levobupivacaine

Placebo Comparator: Placebo
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
Infiltration of the banks of the episiotomy done with physiological serum




Primary Outcome Measures :
  1. ENS pain scale [ Time Frame: 24h post partum ]
    Pain evaluation on a simple numeric scale (ENS)


Secondary Outcome Measures :
  1. Painkillers (ketoprofen) quantity [ Time Frame: During the first 48h post partum ]
    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.

  2. Painkillers (nefopam) quantity [ Time Frame: During the first 48h post partum ]
    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.

  3. Painkillers (ketoprofen) quantity [ Time Frame: At day 15 post-partum ]
    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.

  4. Painkillers (nefopam) quantity [ Time Frame: At day 15 post-partum ]
    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.

  5. Painkillers (paracetamol) quantity [ Time Frame: At day 15 post-partum ]
    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.

  6. ENS pain scale [ Time Frame: At day 15 post-partum ]
    Pain evaluation on a simple numeric scale (ENS)

  7. Presence/absence of complications [ Time Frame: At day 15 post-partum ]
    The quality of cicatrisation of the episiotomy will be assessed in order to track complications.

  8. Likert scale [ Time Frame: Day 1 post partum ]
    Impact of pain secondary to episiotomy on the activities of daily life (sitting, walking, urination, sleep, child care), assessed by the Likert scale

  9. Likert scale [ Time Frame: Day 2 post partum ]
    Impact of pain secondary to episiotomy on the activities of daily life (sitting, walking, urination, sleep, child care), assessed by the Likert scale

  10. Likert scale [ Time Frame: Day 15 post partum ]
    Impact of pain secondary to episiotomy on the activities of daily life (sitting, walking, urination, sleep, child care), assessed by the Likert scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796547


Locations
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Belgium
CHU Brugmann
Brussels, Belgium, 1020
France
CHU Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
Brugmann University Hospital
Investigators
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Principal Investigator: André Nazac, MD CHU Brugmann
Principal Investigator: Florent FUCHS, MD University Hospital, Montpellier

Publications:

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Responsible Party: Andre Nazac, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT02796547     History of Changes
Other Study ID Numbers: CHUB-EQUIDOL
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andre Nazac, Brugmann University Hospital:
Episiotomy
Levobupivacaine

Additional relevant MeSH terms:
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Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents