Status:
COMPLETED
Pain Reduction After Cholecystectomy
Lead Sponsor:
Meander Medical Center
Conditions:
Cholecystolithiasis
Postoperative Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
To determine the effect of combined intracutaneous infiltration and intraperitoneal instillation of 80 mL 0,125% levobupivacaine prior to the start of laparoscopic cholecystectomy on abdominal pain up...
Detailed Description
The primary endpoint of this study was postoperative abdominal pain as measured by a visual analogue scale (VAS), using a VAS lineal with a slide. The patient was asked to indicate a score from 0 to 1...
Eligibility Criteria
Inclusion
- between 18 and 80
- ASA I or II
- with symptomatic gallstone disease which requires elective laparoscopic cholecystectomy
Exclusion
- acute cholecystitis, cholangitis, severe acute pancreatitis, advanced liver cirrhosis or suspected gallbladder cancer,
- a medical history of epilepsy, cardiac arrhythmias or chronic pain of any kind, - allergy to amid type drugs
- pregnancy
- patients suffering from hypotension or hypovolemia
- infectious liver disease
- conditions obstructing adequate pain scoring
- patients using drugs that deduce function of the CYP3A4 or CYP1A2 system
- patients having an American Society of Anaesthesiologists (ASA) classification of three or higher.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01199406
Start Date
July 1 2009
End Date
January 1 2010
Last Update
September 13 2010
Active Locations (1)
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1
Meander MC
Amersfoort, Amersfoort, Netherlands, 3811ES