Paravertebral Block, an Adjunct to General Anaesthesia for Breast Surgery?
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|ClinicalTrials.gov Identifier: NCT00547989|
Recruitment Status : Completed
First Posted : October 23, 2007
Last Update Posted : June 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: standard anaesthesia (bupivacaine) Drug: additional pvb (ropivacaine) and elastomeric disposable infusion pump Drug: additional pvb (ropivacaine)||Phase 3|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Paravertebral Block, an Adjunct to General Anaesthesia for Breast Surgery?|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||May 2011|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547989
|Principal Investigator:||Esther Bouman, MD||azM|