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

Ullevaal University Hospital

Status and phase: Completed; Phase 2

Conditions: Breast Reconstruction

Treatments: Drug: bupivacain; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00804674

01

Details and patient eligibility

About

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

Enrollment: 47 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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47 participants in 2 patient groups, including a placebo group

1 bupivacain

Active Comparator group

Treatment:

Drug: bupivacain

2 placebo

Placebo Comparator group

Treatment:

Drug: placebo