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

NCT ID: NCT00547989

Last Updated: 2014-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2011-05-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

control

Group Type: ACTIVE_COMPARATOR

standard anaesthesia (bupivacaine)

Intervention Type: DRUG

Local infiltration with bupivacaine and Piritramide and Paracetamol as postoperative analgesic, and ondansetron as required

2

PVB with ropivacaine and postoperative pump 5ml/h

Group Type: EXPERIMENTAL

additional pvb (ropivacaine) and elastomeric disposable infusion pump

Intervention Type: DRUG

Patients in group 2 will receive PVB with ropivacaine and postoperative pump 5ml/h.

Experimental 1

PVB with ropivacaine, 10 patients included but not analysed

Group Type: EXPERIMENTAL

additional pvb (ropivacaine)

Intervention Type: DRUG

Patients in group 1 will receive PVB with ropivacaine

Interventions

standard anaesthesia (bupivacaine)

Local infiltration with bupivacaine and Piritramide and Paracetamol as postoperative analgesic, and ondansetron as required

Intervention Type: DRUG

additional pvb (ropivacaine) and elastomeric disposable infusion pump

Patients in group 2 will receive PVB with ropivacaine and postoperative pump 5ml/h.

Intervention Type: DRUG

additional pvb (ropivacaine)

Patients in group 1 will receive PVB with ropivacaine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esther Bouman, MD

Role: PRINCIPAL_INVESTIGATOR

azM

Locations

University Hospital

Maastricht, , Netherlands

Countries

Netherlands

Other Identifiers

MEC 05-105.5

Identifier Type: -

Identifier Source: org_study_id