Effect of levobupivacaine infiltration versus placebo on perineal postpartum pain in episiotomy of primiparous, after instrumental delivery.

Effect of levobupivacaine infiltration versus placebo on perineal postpartum pain in episiotomy of primiparous, after instrumental delivery: randomized double blind clinical trial.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005247-14-BE

Enrollment

330

Registered

2016-06-30

Start date

2016-08-09

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Episiotomy (inclusion of primiparous patients giving birth by instrumental delivery -Suzor forceps, vacuum extraction, Thierry spatulas with episiotomy).

Interventions

Trade Name: Levobupivacaïne Fresenius Kabi Pharmaceutical Form: Solution for injection INN or Proposed INN: LEVOBUPIVACAINE HYDROCHLORIDE CAS Number: 27262-48-2 Other descriptive name: LEVOBUPIVACAINE

Eligibility

Sex/Gender

All

Inclusion 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 -Patient having a good understanding of French Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 330 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Ineffective epidural analgesia, defined as the need of an additional local anesthesia for episiotomy repair - Perineal tear of 3rd and 4rd grade, according to the Anglo-saxon classification - Contra-indication to levobupivacaine, paracetamol, ketoprofen - Protocol participation refusal - Postpartum hemorrhage requiring arterial embolization, reoperation (evacuation of a vaginal thrombus, vessel ligation, hysterectomy by laparotomy) or balloon Bakri® placement.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of the infiltration of levobupivacaine versus placebo on perineal pain after episiotomy in patients under epidural anesthesia.;Secondary Objective: - Estimate the amount of analgesics taken in the first 48 hours, then in the first 15 days postpartum - Evaluate the slowing down of the daily activities of patients within the first 15 days postpartum - Assess the pain at J15 postpartum on a simple numeric scale - Evaluate the healing of episiotomy at J15 postpartum;Primary end point(s): Pain evaluation on a simple numeric scale (ENS) ;Timepoint(s) of evaluation of this end point: 24 h post partum	—

Measure

Time frame

Main Objective: To evaluate the effect of the infiltration of levobupivacaine versus placebo on perineal pain after episiotomy in patients under epidural anesthesia.;Secondary Objective: - Estimate the amount of analgesics taken in the first 48 hours, then in the first 15 days postpartum - Evaluate the slowing down of the daily activities of patients within the first 15 days postpartum - Assess the pain at J15 postpartum on a simple numeric scale - Evaluate the healing of episiotomy at J15 postpartum;Primary end point(s): Pain evaluation on a simple numeric scale (ENS) ;Timepoint(s) of evaluation of this end point: 24 h post partum

—

Secondary

Measure	Time frame
Secondary end point(s): - Need for analgesics and quantity of analgesics taken in addition to paracetamol in the first 48 hours postpartum (ketoprofen, nefopam). - Need for analgesics and amount of analgesics taken on Day 15 postpartum - Impact of pain secondary to episiotomy on the daily life activities on Day1, Day2 and Day15 after delivery (sitting, walking, urinating, sleep, child care). - ENS on Day 15 post-partum - Control of episiotomy healing at Day15 post partum;Timepoint(s) of evaluation of this end point: - Need for analgesics :in the first 48 hours postpartum - Need for analgesics : on Day 15 postpartum - Impact of pain secondary to episiotomy on the daily life activities: Day1, Day2 and Day15 after delivery - ENS on Day 15 post-partum - Control of episiotomy healing at Day15 post partum	—

Measure

Time frame

Secondary end point(s): - Need for analgesics and quantity of analgesics taken in addition to paracetamol in the first 48 hours postpartum (ketoprofen, nefopam). - Need for analgesics and amount of analgesics taken on Day 15 postpartum - Impact of pain secondary to episiotomy on the daily life activities on Day1, Day2 and Day15 after delivery (sitting, walking, urinating, sleep, child care). - ENS on Day 15 post-partum - Control of episiotomy healing at Day15 post partum;Timepoint(s) of evaluation of this end point: - Need for analgesics :in the first 48 hours postpartum - Need for analgesics : on Day 15 postpartum - Impact of pain secondary to episiotomy on the daily life activities: Day1, Day2 and Day15 after delivery - ENS on Day 15 post-partum - Control of episiotomy healing at Day15 post partum

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Countries

Belgium

Contacts

Public ContactGynecology-Obstetrics Department

CHU Brugmann

andre.nazac@chu-brugmann.be322477.29.30

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026