A study comparing an injection on the fat near the phrenic nerve in the chest cavity reduces the pain after open thoractomy surgery
| ISRCTN | ISRCTN11935052 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11935052 |
| Secondary identifying numbers | 14/NW/0003 |
- Submission date
- 02/02/2016
- Registration date
- 27/07/2016
- Last edited
- 22/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
1st floor, CT theatres
Wythenshawe Hospital
South Manchester
M23 9LT
United Kingdom
Study information
| Study design | Single-centre single-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | A randomised prospective study comparing phrenic nerve infiltration vs non-phrenic nerve infiltration on open thoracotomy |
| Study objectives | The infiltration of phrenic nerve during surgery may reduce the certain focal areas of pain associated with an open thoracotomy surgical procedure. |
| Ethics approval(s) | Greater Manchester North West Ethics Committee, 05/04/2014, ref: 14/NW/003 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 20/09/2013 |
| Completion date | 20/09/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key 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 |
| Key exclusion criteria | 1. Patients who are having epidural anaesthesia 2. Patients undergoing emergency operation 3. Refusal to take part in the study |
| Date of first enrolment | 30/06/2014 |
| Date of final enrolment | 05/05/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southmoor Road
Manchester
M23 9LT
United Kingdom
Sponsor information
Research organisation
Research and Development
NIHR building
University Hospital of South Manchester NHS Foundation Trust
South Manchester
M23 9LT
United Kingdom
"ROR" |
https://ror.org/00he80998 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned dissemination of abstracts in thoracic surgery meetings and results publications in scientific journals. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2018 | 22/01/2019 | Yes | No |
Editorial Notes
22/01/2019: Publication reference added
