Pain Study Using Intermittent Bupivacain Injections After Breast Reconstruction With DIEP Flap

NCT ID: NCT00804674

Last Updated: 2011-07-01

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

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-05-31

Brief Summary

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patients are given bupivacain intermittent locally on the donor site after brest reconstruction with diep flap. The hypothesis was that this approach will reduce the need for rescue analgetic medication and pain perception within the three first days

Detailed Description

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Conditions

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Breast Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1 bupivacain

Group Type ACTIVE_COMPARATOR

bupivacain

Intervention Type DRUG

2 placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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bupivacain

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* all patients planned to undergo reconstructive breast surgery with a DIEP

Exclusion Criteria

* regular use of analgesics
* known allergic reaction to bupivacain
* bleeding disorders
* pregnancy
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ullevaal University Hospital

OTHER

Sponsor Role lead

Responsible Party

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ullevaal university hospital

Principal Investigators

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jørgen utvoll, MD

Role: PRINCIPAL_INVESTIGATOR

Consultant at ullevaal university hospital

Other Identifiers

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01

Identifier Type: -

Identifier Source: org_study_id

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