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

NCT02796547 | Withdrawn Phase 2

• 1 other identifier: CHUB-EQUIDOL
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

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.

Conditions

Episiotomy

Keywords

Episiotomy; Levobupivacaine

Outcome Measures

Primary Outcomes (1)

• ENS pain scale

  Pain evaluation on a simple numeric scale (ENS)

  24h post partum

Secondary Outcomes (10)

• Painkillers (ketoprofen) quantity

  During the first 48h post partum

• Painkillers (nefopam) quantity

  During the first 48h post partum

• Painkillers (ketoprofen) quantity

  At day 15 post-partum

• Painkillers (nefopam) quantity

  At day 15 post-partum

• Painkillers (paracetamol) quantity

  At day 15 post-partum

Study Arms (2)

Levobupivacaine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Levobupivacaine DRUG

Infiltration of the banks of the episiotomy done with Levobupivacaine

Levobupivacaine

Physiological serum OTHER

Infiltration of the banks of the episiotomy done with physiological serum

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (2)

CHU Brugmann

Brussels, 1020, Belgium

Location

CHU Montpellier

Montpellier, 34295, France

Location

Related Publications (17)

• Vendittelli F, Gallot D. [What are the epidemiologic data in regard to episiotomy?]. J Gynecol Obstet Biol Reprod (Paris). 2006 Feb;35(1 Suppl):1S12-1S23. French.

  PMID: 16495823 BACKGROUND

• de Tayrac R, Panel L, Masson G, Mares P. [Episiotomy and prevention of perineal and pelvic floor injuries]. J Gynecol Obstet Biol Reprod (Paris). 2006 Feb;35(1 Suppl):1S24-1S31. French.

  PMID: 16495824 BACKGROUND

• College National de Gynecolegues et Obstetriciens Francais. [Text of the guideline for episiotomy]. J Gynecol Obstet Biol Reprod (Paris). 2006 Feb;35(1 Suppl):1S77-1S80. No abstract available. French.

  PMID: 16495830 BACKGROUND

• Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.

  PMID: 15507941 BACKGROUND

• Albers L, Garcia J, Renfrew M, McCandlish R, Elbourne D. Distribution of genital tract trauma in childbirth and related postnatal pain. Birth. 1999 Mar;26(1):11-7. doi: 10.1046/j.1523-536x.1999.00011.x.

  PMID: 10352050 BACKGROUND

• Peter EA, Janssen PA, Grange CS, Douglas MJ. Ibuprofen versus acetaminophen with codeine for the relief of perineal pain after childbirth: a randomized controlled trial. CMAJ. 2001 Oct 30;165(9):1203-9.

  PMID: 11706909 BACKGROUND

• Hedayati H, Parsons J, Crowther CA. Rectal analgesia for pain from perineal trauma following childbirth. Cochrane Database Syst Rev. 2003;(3):CD003931. doi: 10.1002/14651858.CD003931.

  PMID: 12917995 BACKGROUND

• White PF. The changing role of non-opioid analgesic techniques in the management of postoperative pain. Anesth Analg. 2005 Nov;101(5 Suppl):S5-S22. doi: 10.1213/01.ANE.0000177099.28914.A7.

  PMID: 16334489 BACKGROUND

• Marret E, Kurdi O, Zufferey P, Bonnet F. Effects of nonsteroidal antiinflammatory drugs on patient-controlled analgesia morphine side effects: meta-analysis of randomized controlled trials. Anesthesiology. 2005 Jun;102(6):1249-60. doi: 10.1097/00000542-200506000-00027.

  PMID: 15915040 BACKGROUND

• Brennan TJ, Zahn PK, Pogatzki-Zahn EM. Mechanisms of incisional pain. Anesthesiol Clin North Am. 2005 Mar;23(1):1-20. doi: 10.1016/j.atc.2004.11.009.

  PMID: 15763408 BACKGROUND

• Kawamata M, Watanabe H, Nishikawa K, Takahashi T, Kozuka Y, Kawamata T, Omote K, Namiki A. Different mechanisms of development and maintenance of experimental incision-induced hyperalgesia in human skin. Anesthesiology. 2002 Sep;97(3):550-9. doi: 10.1097/00000542-200209000-00006.

  PMID: 12218519 BACKGROUND

• Sanford M, Keating GM. Levobupivacaine: a review of its use in regional anaesthesia and pain management. Drugs. 2010 Apr 16;70(6):761-91. doi: 10.2165/11203250-000000000-00000.

  PMID: 20394458 BACKGROUND

• Ausems ME, Hulsewe KW, Hooymans PM, Hoofwijk AG. Postoperative analgesia requirements at home after inguinal hernia repair: effects of wound infiltration on postoperative pain. Anaesthesia. 2007 Apr;62(4):325-31. doi: 10.1111/j.1365-2044.2007.04991.x.

  PMID: 17381566 BACKGROUND

• Franchi M, Cromi A, Scarperi S, Gaudino F, Siesto G, Ghezzi F. Comparison between lidocaine-prilocaine cream (EMLA) and mepivacaine infiltration for pain relief during perineal repair after childbirth: a randomized trial. Am J Obstet Gynecol. 2009 Aug;201(2):186.e1-5. doi: 10.1016/j.ajog.2009.04.023. Epub 2009 Jun 26.

  PMID: 19560111 BACKGROUND

• Minassian VA, Jazayeri A, Prien SD, Timmons RL, Stumbo K. Randomized trial of lidocaine ointment versus placebo for the treatment of postpartum perineal pain. Obstet Gynecol. 2002 Dec;100(6):1239-43. doi: 10.1016/s0029-7844(02)02339-6.

  PMID: 12468168 BACKGROUND

• Kafali H, Iltemur Duvan C, Gozdemir E, Simavli S, Ozturk Turhan N. Placement of bupivacaine-soaked Spongostan in episiotomy bed is effective treatment modality for episiotomy-associated pain. J Minim Invasive Gynecol. 2008 Nov-Dec;15(6):719-22. doi: 10.1016/j.jmig.2008.08.006.

  PMID: 18971135 BACKGROUND

• Sillou S, Carbonnel M, N'Doko S, Dhonneur G, Uzan M, Poncelet C. [Postpartum perineal pain: effectiveness of local ropivacaine infiltration]. J Gynecol Obstet Biol Reprod (Paris). 2009 Oct;38(6):510-5. doi: 10.1016/j.jgyn.2009.03.008. Epub 2009 Jun 2. French.

  PMID: 19493636 BACKGROUND

MeSH Terms

Interventions

Levobupivacaine

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• André Nazac, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

• Florent FUCHS, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 10, 2016
• Study Start: July 14, 2016
• Primary Completion: May 29, 2018
• Study Completion: May 29, 2018
• Last Updated: July 13, 2018

Record last verified: 2018-07

Locations

FR (1); BE (1)