Pregabalin in pain control after abdominal hysterectomy
- Conditions
- Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]The presence of acute postoperative pain remains a major cause of preoperative morbidity.The objective is to evaluate the analgesic efficacy of pregabalin in thepostoperatory of abdominal hysterectomy associated with 3 types of anesthesia.
- Registration Number
- EUCTR2010-024538-51-ES
- Lead Sponsor
- Silvia Gil Trujillo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assess the analgesic efficacy of pregabalin in postoperative abdominal<br>hysterectomy to associate with three types of anesthesia: general anesthesia total<br>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). -<br>Satisfaction of the patient.;Primary end point(s): The analgesic efficacy of pregabalin was assessed by 2 variables in the immediate<br>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<br>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.<br>
- Secondary Outcome Measures
Name Time Method 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