Individual pain management in day surgery
- Conditions
- MedDRA version: 18.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-004515-20-FI
- Lead Sponsor
- Vesa Kontinen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Laparoscopic cholecystectomy, age over 18 and under 70, ASA classification 1-2 , weight over 50 kg, willing to participate, able to use the NRS scale in the assessment of pain, finnish speaking.
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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
Age under 18, age over 70, ASA classification 3-5, weight under 50 kg, BMI over 40 kg/m2, pregnancy, breastfeeding, allergy for pregabalin, current use of pregabalin or gabapentinoids, unable to use the NRS scale, not willing to participate, not able to give written consent.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Does pregabalin given based on the risk analysis on each patient reduce postoperative pain at 60 min after laparoscopic cholecystectomy.;Secondary Objective: Does pregabalin given based on the risk analysis on each patient reduce the consumption of analgesics and side effects after laparoscopic cholecystectomy;Primary end point(s): Postoperative pain.;Timepoint(s) of evaluation of this end point: 1 hour after the operation.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Postoperative pain, consumption of analgesics, side effects as nausea, vomiting, dizziness, headache, drowsiness.<br>;Timepoint(s) of evaluation of this end point: On the operation day, firts postoperative day, third postoperative day, 1 month after the operation.