Paravertebral Block, an Adjunct to General Anaesthesia for Breast Surgery?
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- reduction of unplanned admissions and reduction of VAS score.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
control
Intervention: standard anaesthesia (bupivacaine) (Drug)
2
PVB with ropivacaine and postoperative pump 5ml/h
Intervention: additional pvb (ropivacaine) and elastomeric disposable infusion pump (Drug)
Experimental 1
PVB with ropivacaine, 10 patients included but not analysed
Intervention: additional pvb (ropivacaine) (Drug)
Outcomes
Primary Outcomes
reduction of unplanned admissions and reduction of VAS score.
Time Frame: one week
Secondary Outcomes
- to determine the safety and performance (efficacy) of the technique and the investigational product.(one week)