A Randomised Controlled Trial to investigate the effectiveness of Thoracic Epidural and Paravertebral Blockade In reducing Chronic Post- Thoracotomy Pain: 2
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TOPIC 2 is a multi-centre, open label, parallel group, superiority randomised controlled, with an internal pilot,of 1026 adult (≥18 years old) thoracotomy patients in a 1:1 ratio.
The aim of TOPIC 2 is to test the hypothesis that in adult patients undergoing elective open thoracotomy, the use of paravertebral blockade for peri-operative pain relief reduces the incidence of chronic pain at six months post randomisation by at least 10% compared with thoracic epidural blockade.
TOPIC 2 aims to recruit at least twenty large adult UK thoracic centres with a track record of successful recruitment to clinical trials and typical patient case mix.
People experience pain differently to one another and to be sure that the trial answers the question definitively we are proposing to conduct a large clinical trial of 1026 adult thoracotomy patients.
The primary outcome:
Incidence of CPTP at 6 months post-randomisation. Participants will be asked to indicate their 'worst chest pain over the last week' on a visual analogue scale (VAS; 0-100). Incidence will be taken to be a score greater or equal to 40 indicating at least a moderate level of pain.
Secondary outcomes measured at 3, 6 and 12 months post randomisation:
There are a number of secondary outcome measures from the time of randomisation. The following is a non-exhaustive list. For a full list please refer to the TOPIC 2 protocol, section 8.2.
- Complications of regional analgesia
- Occurrence and severity of surgical complications until discharge from hospital
- post-operative pulmonary complications (PPCs) until discharge from hospital
- critical care admission (levels 2 and 3)
- mortality (reported for all deaths due to all causes)
- analgesic use
- acute pain (during initial trial admission), pain at discharge from hospital and chronic pain at 3, 6 and 12 months post randomisation.
- resource use and cost data (resource use intraoperatively, during and following hospital admission, and at 3, 6 and 12 months post randomisation.
- general health-related quality of life (by EQ-5D-5L, completed by the participant at discharge and at 3, 6 and 12 months)
- mental health state (measured by HADS, completed by the participant at discharge and at 3, 6 and 12 months)
- Patient satisfaction (by Likert scale, completed by the participant at sicharge and at 3, 6 12 months)
- Serious Adverse Events
Current recruitment progress:
Chief Investigator: Professor Fang Gao Smith
Trial Sponsor: University of Birmingham
Coordinating Centre: Birmingham Clinical Trials Unit (BCTU)
Funding: The National Institute for Health Research Health Technology Assessment (NIHRHTA)
Research Ethics Committee: South East Scotland (Ref: 18/SS/0131) (15th November 2018)
ClinicalTrials.gov Identifier: NCT03677856
NIHR CRN Study ID: 38673