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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00547989
First received: October 18, 2007
Last updated: June 10, 2014
Last verified: June 2014

October 18, 2007
June 10, 2014
October 2006
December 2010   (final data collection date for primary outcome measure)
reduction of unplanned admissions and reduction of VAS score. [ Time Frame: one week ] [ Designated as safety issue: No ]
reduction of unplanned admissions and reduction of VAS score. [ Time Frame: one week ]
Complete list of historical versions of study NCT00547989 on ClinicalTrials.gov Archive Site
to determine the safety and performance (efficacy) of the technique and the investigational product. [ Time Frame: one week ] [ Designated as safety issue: No ]
to determine the safety and performance (efficacy) of the technique and the investigational product. [ Time Frame: one week ]
Not Provided
Not Provided
 
Paravertebral Block, an Adjunct to General Anaesthesia for Breast Surgery?
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: standard anaesthesia (bupivacaine)
    Local infiltration with bupivacaine and Piritramide and Paracetamol as postoperative analgesic, and ondansetron as required
  • Drug: additional pvb (ropivacaine) and elastomeric disposable infusion pump
    Patients in group 2 will receive PVB with ropivacaine and postoperative pump 5ml/h.
  • Drug: additional pvb (ropivacaine)
    Patients in group 1 will receive PVB with ropivacaine
  • Active Comparator: 1
    control
    Intervention: Drug: standard anaesthesia (bupivacaine)
  • Experimental: 2
    PVB with ropivacaine and postoperative pump 5ml/h
    Intervention: Drug: additional pvb (ropivacaine) and elastomeric disposable infusion pump
  • Experimental: Experimental 1
    PVB with ropivacaine, 10 patients included but not analysed
    Intervention: Drug: additional pvb (ropivacaine)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
May 2011
December 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00547989
MEC 05-105.5
No
Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: Esther Bouman, MD azM
Maastricht University Medical Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP