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

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004833-10-ES

Enrollment

248

Registered

2017-12-22

Start date

2018-01-15

Completion date

Unknown

Last updated

2019-02-28

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

Conditions

perineal pain and dyspareunia postpartum

Interventions

Trade Name: CHIROCANE 5 mg/ml Product Name: Levobupivacaina Product Code: 886606 Pharmaceutical Form: Solution for injection INN or Prop

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: to assess the effectiveness at 6 months, defined as perineal pain mesaured in the analog vidual scale EVA, after local application of local anesthetic and corticoids versus the local infiltration of local anesthetic; Secondary Objective: Perineal pain at 2 months. Evaluate the evolution of postpartum dyspareunia at 2 months and at 6 months. Evaluate the influence of the medical and sociocultural variables that influence the response ;Primary end point(s): Score at 6 months in the EVA scale;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Main Objective: to assess the effectiveness at 6 months, defined as perineal pain mesaured in the analog vidual scale EVA, after local application of local anesthetic and corticoids versus the local infiltration of local anesthetic; Secondary Objective: Perineal pain at 2 months. Evaluate the evolution of postpartum dyspareunia at 2 months and at 6 months. Evaluate the influence of the medical and sociocultural variables that influence the response ;Primary end point(s): Score at 6 months in the EVA scale;Timepoint(s) of evaluation of this end point: 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): Score at 2 months in the EVA scale;Timepoint(s) of evaluation of this end point: 6 months	—

Countries

Spain

Contacts

Public ContactDirector

Fundación para la Investigacion Biomédica del Hospital Universitario Príncipe de Asturias

juanantonio.solano@salud.madrid.org+349188781002605

Outcome results

None listed

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