Analgesic efficacy of interpleural and paravertebral block

ISRCTN ISRCTN13324055
DOI https://doi.org/10.1186/ISRCTN13324055
Secondary identifying numbers Version 3
Submission date
13/10/2014
Registration date
10/11/2014
Last edited
02/02/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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
jonowomack@doctors.org.uk

Contact information

Dr Mritunjay Varma
Scientific

Anaesthetic Department
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Phone +44 (0)191 233 6161
Email Mritunjay.Varma@nuth.nhs.uk

Study information

Study designProspective randomised double-blind trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA comparison of the analgesic efficacy of interpleural and ultrasound guided thoracic paravertebral block for mastectomy: a double blinded randomised trial
Study acronymPVIPM
Study objectivesDoes ultrasound guided paravertebral block provide better analgesia than interpleural block for patients undergoing simple mastectomy?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAnalgesia for mastectomy
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measureVAS pain score measured at six hourly intervals for the first 24 hours following mastectomy
Secondary outcome measures1. Nausea and vomiting rate
2. 24-hour morphine consumption
Overall study start date01/01/2015
Completion date01/01/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants70
Key inclusion criteria1. Female patients
2. Between the age of 18 and 85
3. Undergoing elective mastectomy at the RVI
Key exclusion criteria1. 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
Date of first enrolment01/01/2015
Date of final enrolment01/01/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Victoria Infirmary
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor information

The Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Jill Peacock
Joint Research Office
Level 6 Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom

Phone +44 (0)191 282 5959
Email Jillian.Peacock@nuth.nhs.uk
ROR logo "ROR" https://ror.org/05p40t847

Funders

Funder type

Government

Newcastle upon Tyne Hospitals NHS Foundation Trust
Government organisation / Local government
Alternative name(s)
Newcastle upon Tyne Hospitals NHS Trust
Location
United Kingdom
National Institute of Academic Anaesthesia (UK) - pending

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

02/02/2018: No publications found, verifying study status with principal investigator.