Paravertebral Block, an Adjunct to General Anaesthesia for Breast Surgery?

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Paravertebral Block, an Adjunct to General Anaesthesia for Breast Surgery?

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: standard anaesthesia (bupivacaine)
* Drug: additional pvb (ropivacaine) and elastomeric disposable infusion pump
* Drug: additional pvb (ropivacaine)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>control | Drug: standard anaesthesia (bupivacaine)<br>* Local infiltration with bupivacaine and Piritramide and Paracetamol as postoperative analgesic, and ondansetron as required<br>|
| Experimental: 2<br>PVB with ropivacaine and postoperative pump 5ml/h | Drug: additional pvb (ropivacaine) and elastomeric disposable infusion pump<br>* Patients in group 2 will receive PVB with ropivacaine and postoperative pump 5ml/h.<br>|
| Experimental: Experimental 1<br>PVB with ropivacaine, 10 patients included but not analysed | Drug: additional pvb (ropivacaine)<br>* Patients in group 1 will receive PVB with ropivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of unplanned admissions and reduction of VAS score. |  | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine the safety and performance (efficacy) of the technique and the investigational product. |  | one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASA class I and II