Plain English Summary
Background and study aims
Surgery through the side of the chest (thoracotomy), usually to treat lung cancer, causes pain postoperatively, with more than a half of patients developing chronic post-thoracotomy pain (CPTP) which can last months or years. This pain can be severe and debilitating, leading to more frequent GP visits, longer sick leave or even unemployment. CPTP will remain a significant health care and economic burden as there has been an increase in lung operations over the last decade of around 60%, and the trend is likely to continue. Thoracic epidural blockade (TEB), numbing nerves on both sides of the chest, and paravertebral blockade (PVB), targeting pain relief to the side of the surgery are two common techniques that provide good pain relief. But crucially, there is evidence that PVB may reduce the likelihood of chronic pain developing afterwards because of its different sites of action from TEB. Here, we seek to investigate clinical and cost effectiveness of PVB on CPTP in a well-designed randomised trial. However there are certain aspects of the trial that need further clarification - such as how many patients will consent to being randomised to PVB or TEB? Which factors motivate, or become barriers for clinicians and patients to agree to be randomised? Are there any technical difficulties that need to be overcome in order to conduct a full trial? This pilot study aims to answer these questions so that the subsequent randomised controlled trial has the best chance of gaining funding and being successful.
Who can participate?
Adults (aged at least 18) about to have a thoracotomy.
What does the study involve?
Participants are randomly allocated to receive TEB or PVB during surgery. Study data is collected before and after surgery and study questionnaires are also completed before surgery and then again after 24 hours, 48 hours, 72 hours, 3 months and then, finally, 6 months after surgery.
What are the possible benefits and risks of participating?
This study is intended to show whether it is feasible to carry out further research with a larger group of patients and to guide us in how such future research, if funded, should be conducted. Whilst there may be no immediate benefits to the participants, the information gained from this study will help us to develop a larger study which will investigate the impact of paravertebral blockade and thoracic epidural blockade has on long term pain and pain relief for patients. The overall aim will be to improve the longer term pain relief and future care for patients who have lung surgery. Paravertebral block and thoracic epidural block are both widely used to provide pain relief to patients after major surgery. Although they provide good quality pain relief, the side effects may include discomfort on insertion, low blood pressure, itchy skin, headache, nausea and vomiting. Very rare complications can include infection, temporary or permanent nerve damage. Taking part in the study will not add to these side effects and participants will be closely monitored by the research team.
Where is the study run from?
Birmingham Heartlands Hospital NHS Trust and Wythenshawe Hospital, Manchester (UK)
When is the study starting and how long is it expected to run for?
December 2014 to December 2016
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Mrs Amy Kerr
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
18096
Study information
Scientific title
A randomised controlled trial to investigate the effectiveness of ThOracic epidural and Paravertebral blockade In reducing Chronic post-thoracotomy pain
Acronym
TOPIC
Study hypothesis
The overall aim of this research is to determine in adult patients who undergo open chest surgery whether perioperative paravertebral blockade (PVB) at thoracotomy results in reducing chronic post-thoracotomy pain compared to thoracic epidural blockade (TEB). To answer this research question with authoritative evidence of clinical and cost effectiveness of PVB, a multi-centre randomised controlled trial with a parallel health economic evaluation is required. However, feasibility studies are the best way to assess feasibility of a large, expensive full-scale study, and in fact are an almost essential pre-requisite. Conducting feasibility prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies. We have therefore designed this multicentre feasibility study comparing the effectiveness of thoracic epidural blockade and paravertebral blockade in reducing chronic post-thoracotomy pain. This study will evaluate feasibility of a substantive trial and study processes by making the following qualitative and quantitative assessments.
Ethics approval
NRES Committee East Midlands - Derby, 24/12/2014, ref: 14/EM/1280
Study design
Both; Interventional and Observational; Design type: Treatment, Qualitative
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 contact details to request a participant information sheet
Condition
Topic: Anaesthesia, perioperative medicine and pain management; Subtopic: Anaesthesia, perioperative medicine and pain management; Disease: All Anaesthesia, perioperative medicine and pain management
Intervention
All adults undergoing planned elective thoracotomy at study sites fulfilling inclusion and exclusion criteria will be approached and the trial written information sheets will be given to them and the study will be discussed fully. Written Informed consent will be obtained. Patients who consent to participate in the trial will be randomised to either receiving TEB or PVB arm which will be delivered during the patients surgery by either a surgeon or anaesthetist trained in the study protocol. Patient will be randomised on the morning of the surgery. If either surgeon or anaesthetist is not available to deliver the intervention, randomisation will not go ahead. Pre and post-surgery study data collection will be performed and study questionnaires will be completed pre-surgery baseline 24, 48, 72 hours following surgery, 3 and 6 months after discharge.
Intervention type
Other
Phase
Drug names
Primary outcome measure
To establish the number of patients randomised as a proportion of those eligible to enter the study.
Secondary outcome measures
1. Assessment of effectiveness of patient identification and screening processes
2. Identification and analysis of any reasons for failure to recruit patients
3. Examination of the educational materials provided to surgeons and anaesthetists to ensure they are fit for purpose
4. Assessment of willingness of surgeons and anaesthetists to participate
5. Assessment of the effectiveness of the randomisation process of patients
6. Assessment of sustainability of single-blinding of patients to treatment allocation
7. Evaluation of robustness of data collection processes during patients hospital stay
8. The proportion of patients followed up at six months
9. Acceptability to and impact on patients of the interventions
10. Assessment of trial processes, including the choice of outcome measures and impact on staff
11. Derivation of the preliminary data from clinical outcome measures to inform the sample size calculation for the substantive study
Overall trial start date
01/12/2014
Overall trial end date
31/12/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged ≥18 years
2. Elective open thoracotomy
3. Able to understand the study information and provide written informed consent
4. American Society of Anaesthesiologists physical status I, II or III
5. Not known to be pregnant
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 75; UK Sample Size: 75
Participant exclusion criteria
1. Contraindication to TEB or PVB e.g. known allergy to local anaesthetics
2. Infection near the proposed puncture site
3. Coagulation disorders
4. Thoracic spine disorders
5. Chest wall resection
6. Emergency thoracic surgery
7. Previous thoracotomy
8. Likely inability to comply with completion of the study questionnaires
Recruitment start date
01/07/2015
Recruitment end date
30/04/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Birmingham Heartlands Hospital NHS Trust (lead)
Critical Care MIDRU
Birmingham Heartlands Hospital
Bordersley Green East
Birmingham
B9 5SS
United Kingdom
Trial participating centre
Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
This pilot study is designed to identify if a substantive trial is possible. Although a definitive answer to the key research question on effectiveness of paravertebral blockade on CPTP can not be provided, the findings of this pilot study will be scientific interest to others in their own right. We plan the dissemination strategy in three aspects. The first will ensure that patients and health professionals are informed of the pilot findings; the second will engage multi-disciplinary to support a proposal of a definitive RCT and the third will prepare for a resubmission of full HTA application dependant on the success of the pilot study.
Patients and Health Professionals: Following consultation with patients who took part in our survey it is clear that alongside publication in the scientific literature,‘plain English’ summary of the pilot study should be produced. This document will be posted to the pilot participants, using the last confirmed contact details provided at initial trial consent. Findings will be more widely available locally through posters in appropriate outpatient rooms and liaising with the wider pool of clinicians in the two pilot sites, including thoracic anaesthetists, surgeons, nurses and physiotherapists.
Multi-disciplinary Specialties: Findings will also be presented at local and national meetings of Association Cardiothoracic Anaesthetists (ACTA), Society of Cardiothoracic Surgeons (SCTS), Perioperative Research Forum UK, National Institute of Academic Anaesthesia (NIAA), Association of Anaesthetists of Great Britain and Ireland (AAGBI) or the Royal Colleges of Surgeons and Anaesthetists (RCS, RCOA). This will capture an extremely large audience of national anaesthetists and surgeons. We will target anaesthetic training programmes by presenting our data alongside thoracic training events. We will seek all opportunities to assess the willingness to randomise throughout the pilot and gain research community support for in a substantive trial should such a RCT be proven feasible.
The study protocol for the full trial will be published in a peer reviewed journal. The results of TOPIC will be published in an HTA monograph, which will include the clinical and cost aspects of the study. These will also be submitted to high impact international journals, aimed at a general audience, rather than niche anaesthetic or surgery journals, to ensure maximum reach of its impact.
Intention to publish date
Participant level data
Stored in repository
Basic results (scientific)
Publication list