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 to 24 hours after surgery.
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 100 corresponding to his or her pain. At 0.5, 2, 4, 8 and 24 hours after the surgical procedure the primary investigator visited the patient to obtain the VAS scores.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
0.125% levobupivacaine 80 mL (100 mg) intraoperative, 20 mL subcutaneously and 60 mL intraperitoneally
Meander MC
Amersfoort, Amersfoort, Netherlands
Abdominal Pain in Visual Analogue Scale (VAS 0-100mm)
Postoperative abdominal pain
Time frame: 24 h postoperatively
Shoulder pain
Postoperative shoulder pain
Time frame: 24 h
Rescue Analgesics
The need of rescue analgesics within the 24h postoperatively
Time frame: 24 h postoperatively
adverse events caused by the investigational procedure or by levobupivacaine itself
Adverse events were defined as neurological or cardial effects attributable to use of levobupivacaine. Adverse events by the procedure such as bleeding were also registered.
Time frame: Intra- and postoperative up to 24 hours
Length of hospital stay
Time frame: Maximum two weeks
intra-operative complications including perforation of the gallbladder, bile duct injury, bowel injury and injury to vascular structures
Time frame: intraoperative, 1 hour
postoperative complications during hospitalisation
Infection, bleeding, embolisation etc.
Time frame: during hospitalisation (up to two weeks)
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