E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
perineal pain and dyspareunia postpartum |
dolor perineal y dispareunia post parto |
|
E.1.1.1 | Medical condition in easily understood language |
Postpartum pain |
Dolor postparto |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
Evaluar si la infiltración con un anestésico local más corticoide mejora la respuesta del dolor perineal a los 6 meses con respecto a la infiltración con anestésico local. La evaluación de la respuesta se realizará mediante la escala visual analógica (EVA). |
|
E.2.2 | Secondary objectives of the trial |
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 |
● Estimar la incidencia de dolor perineal a los 2 meses del parto en las pacientes a estudio. ● Estimar la incidencia de dispareunia a los 2 meses post-parto y evaluar la eficacia del tratamiento sobre la misma a las dos semanas tras tratamiento y a los 6 meses post-parto. ● Evaluar la influencia de las variables médicas y socioculturales que influyen en la respuesta. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
- 18 años o más. - Puérperas tras parto instrumental con episiotomía - Puérperas con expulsivo prolongado > 3 horas con episiotomía - Puérperas con recién nacido > 4000 gr con episiotomía Adicionalmente, la paciente debe presentar dolor perineal, a los dos meses del parto, con una intensidad de al menos 4 en la EVA. |
|
E.4 | Principal 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 |
- Partos < 37 semanas. - Pacientes con alergias o contraindicaciones a los medicamentos del estudio - Infección vaginal activa - Procesos neoplásicos malignos. - Alteraciones de la coagulación por riesgo de sangrado tras la punción. - Alergia a metales - Belonefobia (miedo extremo, incontrolable e irracional hacia las agujas) - Cesárea - Desconocimiento del idioma castellano o incapacidad para otorgar el consentimiento informado - Neuropatía del pudendo establecida -Diabetes Mellitus tipo 1 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Score at 6 months in the EVA scale |
Valor en la escala EVA a los 6 meses |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Score at 2 months in the EVA scale |
Valor en la escala EVA a los 2 meses. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
estudio de no inferioridad |
non-inferiority study |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last visit of the last subject randomized Unefficacy of the treatment Safety issues |
Última visita del último paciente aleatorizado Ineficacia del tratamiento Por cuestiones de seguridad |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |