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

NCT02796547 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-07-13

No results posted yet for this study

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.

Conditions

  • Episiotomy

Interventions

DRUG

Levobupivacaine

Infiltration of the banks of the episiotomy done with Levobupivacaine

OTHER

Physiological serum

Infiltration of the banks of the episiotomy done with physiological serum

Sponsors & Collaborators

  • Brugmann University Hospital

    lead OTHER

Principal Investigators

  • André Nazac, MD · CHU Brugmann

  • Florent FUCHS, MD · University Hospital, Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-14
Primary Completion
2018-05-29
Completion
2018-05-29

Countries

  • Belgium
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02796547 on ClinicalTrials.gov