- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00547989
Paravertebral Block, an Adjunct to General Anaesthesia for Breast Surgery?
Study Overview
Status
Conditions
Detailed Description
Usually breast tumour surgery in the Academic Hospital Maastricht is performed under general anaesthesia. Perioperative pain management consists of paracetamol and naproxen preoperatively, opioids during surgery and local wound infiltration at the end of surgery with 10cc Bupivacaine 0.25%. Postoperative pain management consists of paracetamol, occasionally combined with Naproxen, and if necessary Piritramide 0.2 mg/kg i.m.
Alternatively there is the possibility to perform breast surgery under a thoracic paravertebral block (PVB) with or without general anesthesia.
A PVB according to Eason and Wyatt (1) can be performed preoperatively with insertion of an end-hole catheter T3-T4. With this technique we expect a better pain relief postoperatively.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Maastricht, Netherlands
- University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Extended mamma surgery one-sided
- ASA class I and II
Exclusion Criteria:
- All contra indications for local anaesthesia
- Coagulation disorders
- Infection
- Allergic reactions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
control
|
Local infiltration with bupivacaine and Piritramide and Paracetamol as postoperative analgesic, and ondansetron as required
|
Experimental: 2
PVB with ropivacaine and postoperative pump 5ml/h
|
Patients in group 2 will receive PVB with ropivacaine and postoperative pump 5ml/h.
|
Experimental: Experimental 1
PVB with ropivacaine, 10 patients included but not analysed
|
Patients in group 1 will receive PVB with ropivacaine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
reduction of unplanned admissions and reduction of VAS score.
Time Frame: one week
|
one week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
to determine the safety and performance (efficacy) of the technique and the investigational product.
Time Frame: one week
|
one week
|
Collaborators and Investigators
Investigators
- Principal Investigator: Esther Bouman, MD, azM
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEC 05-105.5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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