Pain Reduction After Cholecystectomy (INTENSE)

This study has been completed.
Sponsor:
Information provided by:
Meander Medical Center
ClinicalTrials.gov Identifier:
NCT01199406
First received: September 9, 2010
Last updated: September 10, 2010
Last verified: September 2010
  Purpose

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 Intervention Phase
Cholecystolithiasis
Postoperative Pain
Drug: Levobupivacaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Meander Medical Center:

Primary Outcome Measures:
  • Abdominal Pain in Visual Analogue Scale (VAS 0-100mm) [ Time Frame: 24 h postoperatively ] [ Designated as safety issue: No ]
    Postoperative abdominal pain


Secondary Outcome Measures:
  • Shoulder pain [ Time Frame: 24 h ] [ Designated as safety issue: No ]
    Postoperative shoulder pain

  • Rescue Analgesics [ Time Frame: 24 h postoperatively ] [ Designated as safety issue: No ]
    The need of rescue analgesics within the 24h postoperatively

  • adverse events caused by the investigational procedure or by levobupivacaine itself [ Time Frame: Intra- and postoperative up to 24 hours ] [ Designated as safety issue: Yes ]
    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.

  • Length of hospital stay [ Time Frame: Maximum two weeks ] [ Designated as safety issue: No ]
  • intra-operative complications including perforation of the gallbladder, bile duct injury, bowel injury and injury to vascular structures [ Time Frame: intraoperative, 1 hour ] [ Designated as safety issue: Yes ]
  • postoperative complications during hospitalisation [ Time Frame: during hospitalisation (up to two weeks) ] [ Designated as safety issue: Yes ]
    Infection, bleeding, embolisation etc.


Enrollment: 80
Study Start Date: July 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199406

Locations
Netherlands
Meander MC
Amersfoort, Netherlands, 3811ES
Sponsors and Collaborators
Meander Medical Center
Investigators
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
  More Information

No publications provided by Meander Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: dr. Consten, Meander medical Center
ClinicalTrials.gov Identifier: NCT01199406     History of Changes
Other Study ID Numbers: Intense Trial
Study First Received: September 9, 2010
Last Updated: September 10, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Meander Medical Center:
gallstone
gallbladder
cholecystectomy
laparoscopic
pain

Additional relevant MeSH terms:
Cholecystolithiasis
Cholelithiasis
Gallstones
Pain, Postoperative
Biliary Tract Diseases
Calculi
Digestive System Diseases
Gallbladder Diseases
Pain
Pathologic Processes
Pathological Conditions, Anatomical
Postoperative Complications
Signs and Symptoms
Bupivacaine
Levobupivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014