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

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00547989
First received: October 18, 2007
Last updated: May 12, 2011
Last verified: May 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Breast Cancer
 Drug: standard anaesthesia (bupivacaine)
Drug: additional pvb (ropivacaine) and elastomeric disposable infusion pump
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Paravertebral Block, an Adjunct to General Anaesthesia for Breast Surgery?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • reduction of unplanned admissions and reduction of VAS score. [ Time Frame: one week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to determine the safety and performance (efficacy) of the technique and the investigational product. [ Time Frame: one week ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: October 2006
Study Completion Date: May 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
control
 Drug: standard anaesthesia (bupivacaine)
Local infiltration with bupivacaine and Piritramide and Paracetamol as postoperative analgesic, and ondansetron as required
Experimental: 2
PVB with ropivacaine and postoperative pump 5ml/h
 Drug: additional pvb (ropivacaine) and elastomeric disposable infusion pump
Patients in group 2 will receive PVB with ropivacaine and postoperative pump 5ml/h.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547989

Locations
Netherlands
University Hospital
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Esther Bouman, MD azM
  More Information

No publications provided

Responsible Party: Esther Bouman, Maastricht University, Department of anaesthesiology
ClinicalTrials.gov Identifier: NCT00547989     History of Changes
Other Study ID Numbers: MEC 05-105.5
Study First Received: October 18, 2007
Last Updated: May 12, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
ASA class I and II

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anesthetics
Bupivacaine
Ropivacaine
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013