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Completed

NCT Number: NCT01199406

Pain Reduction After Cholecystectomy

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.

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Key information

Conditions

Cholecystolithiasis Biliary Tract Diseases Calculi Cholelithiasis Digestive System Diseases Gallbladder Diseases Gallstones Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Meander MC

Amersfoort, 3811ES, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levobupivacaine

Drug

0.125% levobupivacaine 80 mL (100 mg) intraoperative, 20 mL subcutaneously and 60 mL intraperitoneally

Other names: Chirocaine (brand name), NDA 20-997

Primary outcomes

  1. Abdominal Pain in Visual Analogue Scale (VAS 0-100mm)

    Time frame: 24 h postoperatively

    Postoperative abdominal pain

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Meander Medical Center

Other

Registry information

Official study title

Combined Preincisional Infiltration and Intraperitoneal Instillation of Levobupivacaine for Postoperative Pain Reduction After Laparoscopic Cholecystectomy; A Double-blind Placebo-controlled Randomised Clinical Trial

Acronym: INTENSE

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 13, 2010
Registry last updated
Sep 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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