Clinical trial for treatment of portpartum pain through local anesthetic infiltrations vs anesthetic and corticoids

Phase 1

• Conditions: perineal pain and dyspareunia postpartum; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2017-004833-10-ES
• Lead Sponsor: Fundación para la Investigación Biomédica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-22
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 248

Inclusion Criteria

- 18 years-old or older. -Puerperas after instrumental delivery with episiotomy - Puerperas with prolonged expulsion> 3 hours with episiotomy - Puerperas with newborn> 4000 gr with episiotomy In addition, the patient must present perineal pain, at two months of delivery, with an intensity of at least 4 in the EVA scale.
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 248
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Births <37 weeks. - Patients with allergies or contraindications to study drugs - Active vaginal infection - Neoplastic malignant processes. - Coagulation disorders due to bleeding risk after puncture. - Allergy to metals - Belonephobia (extreme fear, uncontrollable and irrational towards the needles) - Caesarean section - Knowledge of the Spanish language or inability to grant informed consent - Established pudendal neuropathy.
- Type 1 Diabetes Mellitus

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified