Clinical trial NCT01199406: Pain Reduction After Cholecystectomy
Official title: Combined Preincisional Infiltration and Intraperitoneal Instillation of Levobupivacaine for Postoperative Pain Reduction After Laparoscopic Cholecystectomy; A Double-blind Placebo-controlled Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cholecystolithiasis
Postoperative Pain
Keywords: gallstone
gallbladder
cholecystectomy
laparoscopic
pain
Lead sponsor: Meander Medical Center
Sponsor class: OTHER
First posted: 2010-09-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 to 24 hours after surgery.

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 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.

Eligibility criteria: Inclusion Criteria:

* between 18 and 80
* ASA I or II
* with symptomatic gallstone disease which requires elective laparoscopic cholecystectomy

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Abdominal Pain in Visual Analogue Scale (VAS 0-100mm)
timeFrame: 24 h postoperatively
Secondary outcomes:
measure: Shoulder pain
timeFrame: 24 h
measure: Rescue Analgesics
timeFrame: 24 h postoperatively
measure: adverse events caused by the investigational procedure or by levobupivacaine itself
timeFrame: Intra- and postoperative up to 24 hours
measure: Length of hospital stay
timeFrame: Maximum two weeks
measure: intra-operative complications including perforation of the gallbladder, bile duct injury, bowel injury and injury to vascular structures
timeFrame: intraoperative, 1 hour
measure: postoperative complications during hospitalisation
timeFrame: during hospitalisation (up to two weeks)
Other outcomes:
Locations:
city: Amersfoort
country: Netherlands
facility: Meander MC
Study officials:
affiliation: Meander MC
name: Werner A Draaisma, MD, PhD
role: STUDY_CHAIR
affiliation: Meander MC
name: Bart Hilvering, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Meander MC
name: Esther CJ Consten, MD, PhD
role: STUDY_DIRECTOR
affiliation: Meander MC
name: Kristine E Kofman, MD
role: STUDY_CHAIR
affiliation: Meander MC
name: Rene M Valk, MD
role: STUDY_CHAIR
affiliation: Meander MC
name: Jarmila DW Van der Bilt, MD
role: STUDY_CHAIR
References:
citation: Hilvering B, Draaisma WA, van der Bilt JD, Valk RM, Kofman KE, Consten EC. Randomized clinical trial of combined preincisional infiltration and intraperitoneal instillation of levobupivacaine for postoperative pain after laparoscopic cholecystectomy. Br J Surg. 2011 Jun;98(6):784-9. doi: 10.1002/bjs.7435. Epub 2011 Mar 17.