EpisiotomyPhase 2NCT02796547
Effect of Levobupivacaine Infiltration on the Post Partum Perineal Pain in Episiotomy, in Primiparous Women After Instrumental Delivery
A Phase 2 study testing Levobupivacaine and Physiological serum in people with Episiotomy, run by Brugmann University Hospital at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Episiotomy
- What is being tested?
- Levobupivacaine and Physiological serum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Jul 2016to 29 May 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Patient under epidural analgesia
- Patient affiliated to a social security scheme
- Good understanding of French
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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.
Read the 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.
- Conditions
- Episiotomy
- Being tested
- Levobupivacaine, Physiological serum
- Keywords
- Episiotomy, Levobupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Infiltration of the banks of the episiotomy done with Levobupivacaine
Physiological serumOther
Infiltration of the banks of the episiotomy done with physiological serum
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Physiological serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
ENS pain scale
Pain evaluation on a simple numeric scale (ENS)
Measured: 24h post partum
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At day 15 post-partum
ENS pain scale
Pain evaluation on a simple numeric scale (ENS)
Measured: At day 15 post-partum
Presence/absence of complications
The quality of cicatrisation of the episiotomy will be assessed in order to track complications.
Measured: 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
Measured: 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
Measured: 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
Measured: Day 15 post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study start14 Jul 2016
- Primary completion29 May 2018
- Study completion29 May 2018
Why it stopped: Lack of human ressources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for EpisiotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Nazac, Brugmann University Hospital
- Investigators
- André Nazac, MD, Principal investigator, CHU BrugmannFlorent FUCHS, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796547
- Sponsor's protocol ID
- CHUB-EQUIDOL
- Status last verified
- Jul 2018
- First submitted
- 2 Jun 2016
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16495823de 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.
PubMed 16495824College 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.
PubMed 16495830Macarthur 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.
PubMed 15507941Albers 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.
PubMed 10352050Peter 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.
PubMed 11706909Hedayati 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.
PubMed 12917995White 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.
PubMed 16334489Marret 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.
PubMed 15915040Brennan 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.
PubMed 15763408Kawamata 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.
PubMed 12218519Sanford 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.
PubMed 20394458Ausems 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.
PubMed 17381566Franchi 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.
PubMed 19560111Minassian 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.
PubMed 12468168
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02796547
- Acronym / sponsor ID
- CHUB-EQUIDOL
- Conditions
- Episiotomy
- Keywords
- Episiotomy, Levobupivacaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of human ressources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 14 Jul 2016 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 29 May 2018 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levobupivacaine | Experimental | Drug: LevobupivacainePrimiparous 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. |
| Placebo | Placebo comparator | Other: Physiological serumPrimiparous 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevobupivacaineInfiltration of the banks of the episiotomy done with Levobupivacaine | Drug | Levobupivacaine |
| Physiological serumInfiltration of the banks of the episiotomy done with physiological serum | Other | Placebo |
Primary outcome
ENS pain scale
Time frame: 24h post partum
Pain evaluation on a simple numeric scale (ENS)
10 secondary outcomes
Painkillers (ketoprofen) quantity
Time frame: During the first 48h post partum
Painkillers (nefopam) quantity
Time frame: During the first 48h post partum
Painkillers (ketoprofen) quantity
Time frame: At day 15 post-partum
Painkillers (nefopam) quantity
Time frame: At day 15 post-partum
Painkillers (paracetamol) quantity
Time frame: At day 15 post-partum
ENS pain scale
Time frame: At day 15 post-partum
Presence/absence of complications
Time frame: At day 15 post-partum
Likert scale
Time frame: Day 1 post partum
Likert scale
Time frame: Day 2 post partum
Likert scale
Time frame: Day 15 post partum
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Background: PubMed 16495823Vendittelli 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.
- Background: PubMed 16495824de 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.
- Background: PubMed 16495830College 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.
- Background: PubMed 15507941Macarthur 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.
- Background: PubMed 10352050Albers 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.
- Background: PubMed 11706909Peter 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.
- Background: PubMed 12917995Hedayati 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.
- Background: PubMed 16334489White 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.
- Background: PubMed 15915040Marret 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.
- Background: PubMed 15763408Brennan 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.
- Background: PubMed 12218519Kawamata 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.
- Background: PubMed 20394458Sanford 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André Nazac, MD principal investigator
CHU Brugmann
Florent FUCHS, MD principal investigator
University Hospital, Montpellier
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levobupivacaine and Physiological serum in people with Episiotomy, run by Brugmann University Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ENS pain scale (time frame: 24h post partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02796547, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.