NCT01199406

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
Last Updated

September 13, 2010

Status Verified

September 1, 2010

Enrollment Period

6 months

First QC Date

September 9, 2010

Last Update Submit

September 10, 2010

Conditions

CholecystolithiasisPostoperative Pain

Keywords

gallstonegallbladdercholecystectomylaparoscopicpain

Outcome Measures

Primary Outcomes (1)

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

    Postoperative abdominal pain

    24 h postoperatively

Secondary Outcomes (6)

  • Shoulder pain

    24 h

  • Rescue Analgesics

    24 h postoperatively

  • adverse events caused by the investigational procedure or by levobupivacaine itself

    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

  • +1 more secondary outcomes

Study Arms (2)

normal saline

PLACEBO COMPARATOR

80 mL 0.9% NaCl

Drug: Levobupivacaine

Levobupivacaine

EXPERIMENTAL

80mL 0.125% levobupivacaine

Drug: Levobupivacaine

Interventions

LevobupivacaineDRUG

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

Also known as: Chirocaine (brand name), NDA 20-997
Levobupivacainenormal saline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meander MC

Amersfoort, Amersfoort, 3811ES, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 21412996DERIVED

MeSH Terms

Conditions

CholecystolithiasisPain, PostoperativeGallstonesPain

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsCalculiPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Werner A Draaisma, MD, PhD

    Meander MC

    STUDY CHAIR

  • Bart Hilvering, MD

    Meander MC

    PRINCIPAL INVESTIGATOR

  • Esther CJ Consten, MD, PhD

    Meander MC

    STUDY DIRECTOR

  • Kristine E Kofman, MD

    Meander MC

    STUDY CHAIR

  • Rene M Valk, MD

    Meander MC

    STUDY CHAIR

  • Jarmila DW Van der Bilt, MD

    Meander MC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2010

First Posted

September 13, 2010

Study Start

July 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

September 13, 2010

Record last verified: 2010-09

Locations

NL(1)