Individual pain management in day surgery

• Register: EUCTR
• Last refreshed on: 11 January 2016
• Main ID: EUCTR2015-004515-20-FI
• Date of registration: 04/01/2016
• Prospective Registration: No
• Primary sponsor: Vesa Kontinen
• Public title: Individual pain management in day surgery
• Scientific title: Targeted pain management based on patient specific risk assesment in ambulatory surgery
• Date of first enrolment: 31/12/2015
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004515-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Finland

Contacts

• Name: Day surgery unit
• Affiliation: Helsinki University Hospital, Jorvi Hospital

• Name: Day surgery unit
• Affiliation: Helsinki University Hospital, Jorvi Hospital

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

MedDRA version: 18.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

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

Primary Outcome(s)

Primary end point(s): Postoperative pain.

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

Timepoint(s) of evaluation of this end point: 1 hour after the operation.

Secondary Outcome(s)

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.

Secondary ID(s)

PAIKIPAIN

Source(s) of Monetary Support

Academic research, no funding