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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00547989
• Other study ID #: MEC 05-105.5
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2007
• Last updated: June 10, 2014
• Start date: October 2006
• Est. completion date: May 2011

Study information

• Verified date: June 2014
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• standard anaesthesia (bupivacaine)
Local infiltration with bupivacaine and Piritramide and Paracetamol as postoperative analgesic, and ondansetron as required
• additional pvb (ropivacaine) and elastomeric disposable infusion pump
Patients in group 2 will receive PVB with ropivacaine and postoperative pump 5ml/h.
• additional pvb (ropivacaine)
Patients in group 1 will receive PVB with ropivacaine

Locations

Country	Name	City	State
Netherlands	University Hospital	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of unplanned admissions and reduction of VAS score.		one week	No
Secondary	to determine the safety and performance (efficacy) of the technique and the investigational product.		one week	No