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Aim is to study if a paravertebral block as an adjunct to general anesthesia is a suitable technique for extended, one sided, breast surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | control |
|
| 2 | Experimental | PVB with ropivacaine and postoperative pump 5ml/h |
|
| Experimental 1 | Experimental | PVB with ropivacaine, 10 patients included but not analysed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard anaesthesia (bupivacaine) | Drug | Local infiltration with bupivacaine and Piritramide and Paracetamol as postoperative analgesic, and ondansetron as required |
|
| Measure | Description | Time Frame |
|---|---|---|
| reduction of unplanned admissions and reduction of VAS score. | one week |
| Measure | Description | Time Frame |
|---|---|---|
| to determine the safety and performance (efficacy) of the technique and the investigational product. | one week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther Bouman, MD | azM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Maastricht | Netherlands |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| additional pvb (ropivacaine) and elastomeric disposable infusion pump | Drug | Patients in group 2 will receive PVB with ropivacaine and postoperative pump 5ml/h. |
|
| additional pvb (ropivacaine) | Drug | Patients in group 1 will receive PVB with ropivacaine |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D000588 |
| Amines |