Condition category
Surgery
Date applied
02/02/2016
Date assigned
27/07/2016
Last edited
27/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Long-term conditions which affect the lungs (chronic lung disease) and the airways are a growing problem worldwide. People with CLD are likely to experience breathlessness and chest pain, especially when exerting themselves, and so sufferers tend to avoid exercise. This can lead to their lung conditions getting worse, causing disability that is both a source of suffering and strain on the health services. Medication can be used to help improve the symptoms of CLD however it does not stop the disease from getting worse in the long term. In many cases, patients undergo surgical procedures such as a lung resection (a procedure in which part of the lung is removed). In order to gain access to the lungs in this procedure, a surgical cut is made in side of the chest (thoracotomy). Following this type of surgery, patients are often in a great deal of pain at the surgical site which can interfere with their recovery. Nerve block procedures are used more and more for post-operative pain relief. An injection of a drug such as bupavacaine (a numbing agent) around a nerve can numb the area, so the patient does not feel pain in the areas the nerve supplies. The aim of this study is to find out whether a nerve block to the phrenic nerve (nerve that supplies the diaphragm, the main muscle involved in breathing) can help to reduce post-operative pain and improve recovery in patients who have had a thoracotomy.

Who can participate?
Adult patients who are having open thoracic (chest) surgery by choice.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive an injection of 10ml 0.25% bupivacaine into the fat surrounding the phrenic nerve (nerve that supplies the diaphragm) at the end of their surgery just before the lungs are re-inflated and the surgical incision is closed. Participants in the second group do not receive any injection into the fat near the phrenic nerve. Participants are asked to rate their level of pain two hours before surgery, and then one, three, six, 12, 24, 48 and 72 hours after surgery. At these times, their lung function is also measured by blowing into a tube attached to a machine which measures how much they are able to blow out.

What are the possible benefits and risks of participating?
There are no direct benefits of taking part in this study. There is a small risk of developing complications following the nerve block procedure, such as pain, numbness or dizziness.

Where is the study run from?
Wythenshawe Hospital (UK)

When is the study starting and how long is it expected to run for?
April 2014 to September 2015

Who is funding the study?
University Hospital of South Manchester NHS Foundation Trust (UK)

Who is the main contact?
Mr Rajesh Shah

Trial website

Contact information

Type

Scientific

Primary contact

Mr Rajesh Shah

ORCID ID

Contact details

1st floor
CT theatres
Wythenshawe Hospital
South Manchester
M23 9LT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14/NW/0003

Study information

Scientific title

A randomised prospective study comparing phrenic nerve infiltration vs non-phrenic nerve infiltration on open thoracotomy

Acronym

Study hypothesis

The infiltration of phrenic nerve during surgery may reduce the certain focal areas of pain associated with an open thoracotomy surgical procedure.

Ethics approval

Greater Manchester North West Ethics Committee, 05/04/2014, ref: 14/NW/003

Study design

Single-centre single-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

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

Condition

Open thoractomy patients undergoing single lung lobe resection

Intervention

Participants are randomly allocated to on of two groups.

Intervention group: Participants receive infiltration of 10ml of 0.25% bupavacaine into the periphrenic fat pad above and below hilum level just before the expansion of the lung and closure of the thoractomy. The phernic nerve infiltration will be performed using a 22-G spinal needle (Becton – Dickinson) inserted into the fat pad near the phrenic nerve at the level of the diaphragm. This fat pad is a site for infiltration, which will act as a reservoir for the local anaesthetic and reducing the risk of intraneural injection and nerve damage.

Control group: Participants do not receive any injection in the fat near the phrenic nerve.

Participants in both groups have their lung function assessed 1, 3, 6,12, 24, 48 and 72 hours post-operatively, as well being monitored for respiratory complications.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Pain is measured using the Likert scale pain scoring system at baseline (2 hours pre-operatively), 1, 3, 6, 12, 24, 48 and 72 hours postoperatively
2. Effect of pain on postoperative peak flow pressure is measured using spirometry at baseline (2 hours pre-operatively), 1, 3, 6, 12, 24, 48 and 72 hours postoperatively

Secondary outcome measures

1. Use of pain medications is assessed by reviewing patient drug charts on discharge from hospital
2. Mobilisation is assessed by reviewing physiotherapy records on discharge from hospital

Overall trial start date

20/09/2013

Overall trial end date

20/09/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients undergoing routine elective thoracic surgery especially open thoracotomy procedure with patient-controlled analgesia (PCA) and epipleural insertion
2. Provision of written informed consent
3. Aged 18 years or over

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Patients who are having epidural anaesthesia
2. Patients undergoing emergency operation
3. Refusal to take part in the study

Recruitment start date

30/06/2014

Recruitment end date

05/05/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wythenshawe Hospital
University Hospital of South Manchester NHS Foundation Trust Southmoor Road
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

University Hospital of South Manchester NHS Foundation Trust

Sponsor details

Research and Development
NIHR building
University Hospital of South Manchester NHS Foundation Trust
South Manchester
M23 9LT
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital of South Manchester NHS Foundation Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned dissemination of abstracts in thoracic surgery meetings and results publications in scientific journals.

Intention to publish date

31/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes