Caesarean delivery MedDRA version: 17.0 Level: LLT Classification code 10006921 Term: Caesarean delivery (infant record) System Organ Class: 100000004865
Conditions
Interventions
Trade Name: BUPIVACAINA HIDROCLORURO, EPINEFRINA BITARTRATO
Product Name: bupivacaina hidrocloruro + epinefrina
Product Code: 615930
Pharmaceutical Form: Solution for injection/infusion
INN or Propose
Sponsors
Carlos Fernandez Galvan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women scheduled for elective cesarean section. Women with a minimum age of 18 years. Risk I and 2 according to the ASA (American Society of Anesthesiologists) 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 84 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Hypersensitivity to any component of the formulation of the study drug. Any other clinical condition or previous therapy that, in the investigator's opinion, the patient would not be eligible to participate in the study or could not meet the requirements of dosage. Prisoners or detainees involuntarily for treatment of a psychiatric or physical illness. Patients unable to give informed consent Infection at the puncture site for epidural anesthesia. Blood clotting problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: assess pain control with static VAS scale at 24 hours in the three groups in our study;Secondary Objective: Valorar el número de rescates analgésicos. Determinar el tiempo transcurrido desde la realización de la técnica hasta la necesidad del primer rescate analgésico (en caso de que se precise). Establecer el tiempo en iniciar la deambulación y la aparición de dolor con la deambulación. Evaluar el numero de días de ingreso hospitalario. Registrar la aparición de efectos secundarios (prurito, náuseas, vómitos, retención urinaria, depresión respiratoria etc);Primary end point(s): postoperative pain after cesarean;Timepoint(s) of evaluation of this end point: 2 hours from the completion of the surgery, at 6, 24 and 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of analgesics bailouts. Time elapsed since the performance of the technique need to first rescue analgesic. Time to start walking and pain with ambulation. Time of hospital discharge. Occurrence of side effects;Timepoint(s) of evaluation of this end point: 2 hours from the completion of the surgery, at 6, 24 and 48 hours | — |
Countries
Spain
Contacts
Public Contactservicio de anestesia
Hospital Clinico San Carlos
Outcome results
None listed