Pain Reduction After Cholecystectomy (INTENSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01199406
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : September 13, 2010
Information provided by:
Meander Medical Center

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.

Condition or disease Intervention/treatment Phase
Cholecystolithiasis Postoperative Pain Drug: Levobupivacaine Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

Arm Intervention/treatment
Placebo Comparator: normal saline
80 mL 0.9% NaCl
Drug: Levobupivacaine
0.125% levobupivacaine 80 mL (100 mg) intraoperative, 20 mL subcutaneously and 60 mL intraperitoneally
Other Names:
  • Chirocaine (brand name)
  • NDA 20-997

Experimental: Levobupivacaine
80mL 0.125% levobupivacaine
Drug: Levobupivacaine
0.125% levobupivacaine 80 mL (100 mg) intraoperative, 20 mL subcutaneously and 60 mL intraperitoneally
Other Names:
  • Chirocaine (brand name)
  • NDA 20-997

Primary Outcome Measures :
  1. Abdominal Pain in Visual Analogue Scale (VAS 0-100mm) [ Time Frame: 24 h postoperatively ]
    Postoperative abdominal pain

Secondary Outcome Measures :
  1. Shoulder pain [ Time Frame: 24 h ]
    Postoperative shoulder pain

  2. Rescue Analgesics [ Time Frame: 24 h postoperatively ]
    The need of rescue analgesics within the 24h postoperatively

  3. adverse events caused by the investigational procedure or by levobupivacaine itself [ Time Frame: Intra- and postoperative up to 24 hours ]
    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.

  4. Length of hospital stay [ Time Frame: Maximum two weeks ]
  5. intra-operative complications including perforation of the gallbladder, bile duct injury, bowel injury and injury to vascular structures [ Time Frame: intraoperative, 1 hour ]
  6. postoperative complications during hospitalisation [ Time Frame: during hospitalisation (up to two weeks) ]
    Infection, bleeding, embolisation etc.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01199406

Meander MC
Amersfoort, Netherlands, 3811ES
Sponsors and Collaborators
Meander Medical Center
Study Chair: Werner A Draaisma, MD, PhD Meander MC
Principal Investigator: Bart Hilvering, MD Meander MC
Study Director: Esther CJ Consten, MD, PhD Meander MC
Study Chair: Kristine E Kofman, MD Meander MC
Study Chair: Rene M Valk, MD Meander MC
Study Chair: Jarmila DW Van der Bilt, MD Meander MC

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: dr. Consten, Meander medical Center Identifier: NCT01199406     History of Changes
Other Study ID Numbers: Intense Trial
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: September 13, 2010
Last Verified: September 2010

Keywords provided by Meander Medical Center:

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents