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Pain Reduction After Cholecystectomy

NCT ID: NCT01199406

Last Updated: 2010-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cholecystolithiasis Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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normal saline

80 mL 0.9% NaCl

Group Type PLACEBO_COMPARATOR

Levobupivacaine

Intervention Type DRUG

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

Levobupivacaine

80mL 0.125% levobupivacaine

Group Type EXPERIMENTAL

Levobupivacaine

Intervention Type DRUG

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

Interventions

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Levobupivacaine

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

Intervention Type DRUG

Other Intervention Names

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Chirocaine (brand name) NDA 20-997

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meander Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Meander medical Center

Principal Investigators

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Werner A Draaisma, MD, PhD

Role: STUDY_CHAIR

Meander MC

Bart Hilvering, MD

Role: PRINCIPAL_INVESTIGATOR

Meander MC

Esther CJ Consten, MD, PhD

Role: STUDY_DIRECTOR

Meander MC

Kristine E Kofman, MD

Role: STUDY_CHAIR

Meander MC

Rene M Valk, MD

Role: STUDY_CHAIR

Meander MC

Jarmila DW Van der Bilt, MD

Role: STUDY_CHAIR

Meander MC

Locations

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Meander MC

Amersfoort, Amersfoort, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 21412996 (View on PubMed)

Other Identifiers

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Intense Trial

Identifier Type: -

Identifier Source: org_study_id