Individual pain management in day surgery

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2015
INTERVENTION: 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: equal Concentration number: 150‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: ; MedDRA version: 18.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863 Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: Does pregabalin given based on the risk analysis on each patient reduce postoperative pain at 60 min after laparoscopic cholecystectomy. Primary end point(s): Postoperative pain. Secondary Objective: Does pregabalin given based on the risk analysis on each patient reduce the consumption of analgesics and side effects after laparoscopic cholecystectomy Timepoint(s) of evaluation of this end point: 1 hour after the operation. SECONDARY OUTCOME: 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. 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
Epistemonikos ID: 7dd5adb8ebea116c30a22c6c7f2e88cdab13e6ab
First added on: Jul 27, 2021