Effect of levobupivacaine infiltration versus placebo on perineal postpartum pain in episiotomy of primiparous, after instrumental delivery.
- Conditions
- Episiotomy (inclusion of primiparous patients giving birth by instrumental delivery -Suzor forceps, vacuum extraction, Thierry spatulas with episiotomy).Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2015-005247-14-BE
- Lead Sponsor
- Centre Hospitalier Universitaire Brugmann
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 330
-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
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method