Research with human participants

Overview of medical research in the Netherlands

Efficacy of a mamma fieldblock in oncological breast surgery in reducing postoperative nausea and pain.

Published:
Last updated:

Reducing postoperative pain and nausea improves patient satisfaction.

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Ethical review
Approved WMO
Status
Pending
Health condition type
Breast therapeutic procedures
Study type
Interventional

ID

NL-OMON30861

Source

ToetsingOnline

Brief title

Efficacy of a mamma fieldblock in oncological breast surgery.

Condition

  • Breast therapeutic procedures

Synonym

postoperative pain and nausea

Research involving

Human

Sponsors and support

Primary sponsor :
Canisius Wilhelmina Ziekenhuis
Source(s) of monetary or material Support :
wetenschapsfonds afdeling anesthesie CWZ;stichting Morpheus

Intervention

Keyword :
breast surgery, field block, postoperative pain

Outcome measures

Primary outcome

Postoperative opioidconsumption. Postoperative pain, nausea and vomiting are

scored using a numeric rating scale.

Secondary outcome

No secundary study parameters/outcome of the study defined

Background summary

Improving postoperative care after oncological breast surgery.

Study objective

Reducing postoperative pain and nausea improves patient satisfaction.

Study design

Double blinded, randomized study

Intervention

Mamma fieldblock.

Study burden and risks

Fieldblock is performed under general anesthesia.
Risk of toxicity is minimalized by perfoming the block lege artis. Like any
puncture hematomes are possible.

Public
Canisius Wilhelmina Ziekenhuis

Weg door Jonkerbos 100
6532 SZ Nijmegen
Nederland
Scientific
Canisius Wilhelmina Ziekenhuis

Weg door Jonkerbos 100
6532 SZ Nijmegen
Nederland

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Female patients for lumpectomy or ablatio mammae with of without axillary lymphnode dissection.

Exclusion criteria

Allergy to local anesthetics. Chronic use pain medication.

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Double blinded (masking used)
Control :
Placebo
Primary purpose :
Prevention

Recruitment

NL
Recruitment status
:
Pending
Start date (anticipated) :
Enrollment :
80
Type :
Anticipated

Medical products/devices used

Product type :
Medicine
Brand name :
naropin
Generic name :
ropivacaine HCl
Registration
:
Yes - NL intended use

Approved WMO
Application type :
First submission
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
EudraCT EUCTR2007-001368-59-NL
CCMO NL17026.091.07