Condition category
Signs and Symptoms
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

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, it’s 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

Trial website

Contact information



Primary contact

Dr Mritunjay Varma


Contact details

Anaesthetic Department
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
United Kingdom
+44 (0) 191 233 6161

Additional identifiers

EudraCT number 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



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Analgesia for Mastectomy


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



Not Applicable

Drug names

Primary outcome measures

To investigate if there is a clinically significant reduction in VAS pain score following mastectomy with either interpleural or ultrasound –guided thoracic paravertebral blocks. Pain scores will be measured at six hourly intervals for the first 24 hours.

Secondary outcome measures

1. Is there a difference nausea and vomiting rate between the two techniques?
2. Is there a difference in 24 hour morphine consumption between the two techniques?

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Female patients
2. Between the age of 18 and 85
3. Undergoing elective mastectomy at the RVI

Participant type


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Anaesthetic Department
Newcastle Upon Tyne
United Kingdom

Sponsor information


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
United Kingdom
+44 (0) 191 282 5959

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Newcastle-upon-Tyne Hospitals NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

National Institute of Academic Anaesthesia (UK) - pending

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes