Plain English Summary
Background and study aims
Injection of local anaesthetic to numb an area of the body is known as regional anaesthesia. This is known to be a very good and safe way of providing pain relief for breast surgery and it avoids many of the side effects of strong pain killers, such as morphine. There are several types of regional anaesthesia used for breast surgery, but at the moment, its not known which one provides the best pain relief. At our institution we commonly use two types of regional anaesthesia - UGTPVB and interpleural block. UGTPVB involves an injection of local anaesthetic to a small area beside the spine which then spreads and blocks the nerves to the chest. In interpleural block, the local anaesthetic is injected into the lining of the lung which then spreads to block the same nerves. Both injections are performed once the patient has been anaesthetised. This study will help anaesthetists and patients decide which of these two pain relief techniques work best. We suspect that UGTPVB provides better pain relief as local anaesthetic is injected close to its point of action but this is not proven. It is easier and quicker to give patients the interpleural block so if we find out that the two techniques provide equal pain relief then interpleural block will be an attractive option for anaesthetists.
Who can participate?
Female patients aged between 18-85 and undergoing a mastectomy at the Royal Victoria Infirmary (UK)
What does the study involve?
Participants are randomly allocated to have either interpleural or UGTPVB. All patients receive the same anaesthetic regardless of technique. Once the patients are anaesthetised, the block is performed by an anaesthetist who is an expert in regional anaesthesia. No one else is aware of which block each patient receives. The patients proceed with their anaesthetic and surgery as normal. After the operation all patients record their pain and nausea scores every six hours and the research team record the amount of morphine each patient needs for the first 24 hours after surgery. We will analyse the data to determine whether USGPVB provides better pain relief than interpleural block. The results will be submitted to an anaesthetic peer reviewed journal for publication.
What are the possible benefits and risks of participating?
By enrolling in the study the participant will receive one of the most effective types of pain relief for their operation. Studies have shown that both techniques provide excellent pain relief with few side effects- especially when compared to morphine based pain relief. Regional anaesthesia is also known to reduce chronic scar pain, a common problem following mastectomy, and there is some evidence that the use of regional anaesthesia may help prevent the cancer from returning. Complications of either type of block are rare and already standard treatments. The most likely complications of a paravertebral block include low blood pressure, bleeding at the site of the injection and puncturing of the lung lining. The most common risk of interpleural block is developing a pneumothorax. Serious complications of both injections are very rare. In any technique where local anaesthetics are used there is a risk of toxicity. The most likely serious complication of local anaesthetic toxicity is a seizure and this occurs in around 1 in 10,000 patients.
Where is the study run from?
The Royal Victoria Infirmary hospital in Newcastle-Upon-Tyne (UK)
When is the study starting and how long is it expected to run for?
January 2015 to January 2016
Who is funding the study?
1. Newcastle-upon-Tyne Hospitals NHS Foundation Trust (UK)
2. National Institute of Academic Anaesthesia (UK) - pending
Who is the main contact?
Dr Jonathan Womack
jonowomack@doctors.org.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mritunjay Varma
ORCID ID
Contact details
Anaesthetic Department
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
+44 (0)191 233 6161
Mritunjay.Varma@nuth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 3
Study information
Scientific title
A comparison of the analgesic efficacy of interpleural and ultrasound guided thoracic paravertebral block for mastectomy: a double blinded randomised trial
Acronym
PVIPM
Study hypothesis
Does ultrasound guided paravertebral block provide better analgesia than interpleural block for patients undergoing simple mastectomy?
Ethics approval
Not provided at time of registration
Study design
Prospective randomised double-blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Analgesia for mastectomy
Intervention
1. Group one will receive ultrasound guided paravertebral block and a standardised anaesthetic
2. Group two will receive interpleural block and the same standardised anaesthetic
Intervention type
Drug
Phase
Not Applicable
Drug names
Primary outcome measure
VAS pain score measured at six hourly intervals for the first 24 hours following mastectomy
Secondary outcome measures
1. Nausea and vomiting rate
2. 24-hour morphine consumption
Overall trial start date
01/01/2015
Overall trial end date
01/01/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Female patients
2. Between the age of 18 and 85
3. Undergoing elective mastectomy at the RVI
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
70
Participant exclusion criteria
1. Any procedure other than sentinel node biopsy in addition to simple mastectomy. This includes axillary node clearance and reconstructions.
2. BMI>35
3. Musculoskeletal deformity
4. Local infection at paravertebral or interpleural injection site
5. Coagulopathy
6. Respiratory disease which limits functional capacity
7. Neurological disease
8. Allergy or contraindication to local anaesthetics, opiates, paracetamol, parecoxib, volatile or intravenous anaesthetics and neuromuscular blockade.
9. Chronic pain treated by long term opiates
10. Psychiatric disease
11. Pregnancy or breast feeding
12. Patient refusal or incapacity
13. Anticipated difficult intubation which would preclude the use of neuromuscular blockade
14. Day case procedure planned
Recruitment start date
01/01/2015
Recruitment end date
01/01/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Victoria Infirmary
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Sponsor information
Organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Sponsor details
c/o Jill Peacock
Joint Research Office
Level 6 Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
+44 (0)191 282 5959
Jillian.Peacock@nuth.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Newcastle upon Tyne Hospitals NHS Foundation Trust
Alternative name(s)
Newcastle upon Tyne Hospitals NHS Trust
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
United Kingdom
Funder name
National Institute of Academic Anaesthesia (UK) - pending
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list