MedDRA version: 18.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Lyrica
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PREGABALIN
CAS Number: 148553-50-8
Other descriptive name: PREGABALIN
Concentration unit: mg milligram(s)
Concentration type
Sponsors
Vesa Kontinen
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Postoperative pain, consumption of analgesics, side effects as nausea, vomiting, dizziness, headache, drowsiness. ;Timepoint(s) of evaluation of this end point: On the operation day, firts postoperative day, third postoperative day, 1 month after the operation. | — |
Countries
Finland
Contacts
Public ContactDay surgery unit
Helsinki University Hospital, Jorvi Hospital
Outcome results
None listed