Paravertebral Block, an Adjunct to General Anaesthesia for Breast Surgery?
|Breast Cancer||Drug: standard anaesthesia (bupivacaine) Drug: additional pvb (ropivacaine) and elastomeric disposable infusion pump Drug: additional pvb (ropivacaine)||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Paravertebral Block, an Adjunct to General Anaesthesia for Breast Surgery?|
- reduction of unplanned admissions and reduction of VAS score. [ Time Frame: one week ]
- to determine the safety and performance (efficacy) of the technique and the investigational product. [ Time Frame: one week ]
|Study Start Date:||October 2006|
|Study Completion Date:||May 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Drug: standard anaesthesia (bupivacaine)
Local infiltration with bupivacaine and Piritramide and Paracetamol as postoperative analgesic, and ondansetron as required
PVB with ropivacaine and postoperative pump 5ml/h
Drug: additional pvb (ropivacaine) and elastomeric disposable infusion pump
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
Drug: additional pvb (ropivacaine)
Patients in group 1 will receive PVB with ropivacaine
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547989
|Principal Investigator:||Esther Bouman, MD||azM|