Pain Reduction After Cholecystectomy (INTENSE)

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Cholecystolithiasis
• Intervention / Treatment: Drug: Levobupivacaine

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
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Amersfoort, Netherlands, 3811ES
    • Meander MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal Pain in Visual Analogue Scale (VAS 0-100mm)	Postoperative abdominal pain	24 h postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder pain	Postoperative shoulder pain	24 h
Rescue Analgesics	The need of rescue analgesics within the 24h postoperatively	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.	Intra- and postoperative up to 24 hours
Length of hospital stay		Maximum two weeks
intra-operative complications including perforation of the gallbladder, bile duct injury, bowel injury and injury to vascular structures		intraoperative, 1 hour
postoperative complications during hospitalisation	Infection, bleeding, embolisation etc.	during hospitalisation (up to two weeks)

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: September 9, 2010
• First Submitted That Met QC Criteria: September 10, 2010
• First Posted (Estimate): September 13, 2010

Study Record Updates

• Last Update Posted (Estimate): September 13, 2010
• Last Update Submitted That Met QC Criteria: September 10, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: pain; cholecystectomy; laparoscopic; gallstone; gallbladder
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Pain, Postoperative; Gallstones; Cholelithiasis; Cholecystolithiasis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Levobupivacaine
• Other Study ID Numbers: Intense Trial