The presence of acute postoperative pain remains a major cause of preoperative morbidity.The objective is to evaluate the analgesic efficacy of pregabalin in the postoperatory of abdominal hysterectomy associated with 3 types of anesthesia.
Conditions
Interventions
Trade Name: Lyrica
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: pregabalina
CAS Number: 148553-50-8
Current Sponsor code: ssgt05
Other descriptive name: PREGABALIN
Concentration unit: mg mi
Sponsors
Silvia Gil Trujillo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients scheduled for abdominal hysterectomy. -Age 18-70 years. - ASA I-II (anesthetic classification system to estimate the risk posed by anesthesia for the different states of the patient, I: no associated pathology and II: mild systemic disease, uncontrolled and disabling)-no known allergies to drugs to manage in the study. - Laboratory tests in the range of normal, and negative pregnant test. 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: Impaired renal function. - History of alcohol or drugs. - Treatment with antacids and antidepressants. - History of diabetes or epilepsy. - Chronic treatment with steroids or at least 4 weeks before surgery. - Mental illness or inability to understand the Spanish. Pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the analgesic efficacy of pregabalin in postoperative abdominal hysterectomy to associate with three types of anesthesia: general anesthesia total intravenous general anesthesia inhalation, and combined anesthesia (regional plus general);Secondary Objective: To assess preoperative anxiety. - Sleep. -Adverse effects (dizziness, somnolence,paresthesia, fatigue, headache, constipation, nausea and vomiting). - Satisfaction of the patient.;Primary end point(s): The analgesic efficacy of pregabalin was assessed by 2 variables in the immediate postoperative period and every 8hours within the first 48 hours, or verbal analog I scale (0-10) at rest and in motion. It is considered good pain control values less than or equal to 3. ;Timepoint(s) of evaluation of this end point: The variables will be recorded during the first 48 hours in the postoperative period. In the operating room, in reanimation care, and in the gynecological ward. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Need to use rescue medication, pain scale according to WHO and milligrams of opiates consumed. anxiety. side effects. patient satisfaction. rest;Timepoint(s) of evaluation of this end point: 48 hours | — |
Countries
Spain
Contacts
Public ContactArea de Ensayos Clínicos
Hospital General de Ciudad Real
Outcome results
None listed