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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: standard anaesthesia (bupivacaine); Drug: additional pvb (ropivacaine) and elastomeric disposable infusion pump; Drug: additional pvb (ropivacaine)

• Registration Number: NCT00547989
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-10-18
• Study First Submitted QC: 2007-10-22
• Study First Posted: 2007-10-23
• Primary Completion: 2010-12
• Study Completion: 2011-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-10
• Last Update Posted: 2014-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	standard anaesthesia (bupivacaine)	control
2	additional pvb (ropivacaine) and elastomeric disposable infusion pump	PVB with ropivacaine and postoperative pump 5ml/h
Experimental 1	additional pvb (ropivacaine)	PVB with ropivacaine, 10 patients included but not analysed

Primary Outcome Measures

Name	Time	Method
reduction of unplanned admissions and reduction of VAS score.	one week

Secondary Outcome Measures

Name	Time	Method
to determine the safety and performance (efficacy) of the technique and the investigational product.	one week

Trial Locations

Locations (1)

University Hospital; 🇳🇱 Maastricht, Netherlands