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Completed

NCT Number: NCT00547989

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

Aim is to study if a paravertebral block as an adjunct to general anesthesia is a suitable technique for extended, one sided, breast surgery.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital

Maastricht, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard anaesthesia (bupivacaine)

Drug

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

additional pvb (ropivacaine) and elastomeric disposable infusion pump

Drug

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

additional pvb (ropivacaine)

Drug

Patients in group 1 will receive PVB with ropivacaine

Primary outcomes

  1. reduction of unplanned admissions and reduction of VAS score.

    Time frame: one week

Secondary outcomes

  1. to determine the safety and performance (efficacy) of the technique and the investigational product.

    Time frame: one week

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Oct 23, 2007
Registry last updated
Jun 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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