About this trial
This is an observational clinical study aiming to further the wider understanding of patients who develop persistent pain after Thoracoabdominal Aorta surgery, a surgical cohort who are disproportionately affected. This will be undertaken through a prospective biopsychosocial characterisation of the phenotype of patients undergoing this operation.
Increasing numbers of patients are undergoing surgery on the chest for treatment of heart or lung cancer disease. Over the last twenty years, the medical community has become increasingly aware of the long-term effect of this surgery in producing persistent pain, approximately half of all survivors are still in pain around their surgical incision at three months postoperatively and beyond. There is currently no accepted method for preventing this phenomenon.
The nervous system mechanisms for the development of persistent pain after surgery are unclear. Some studies suggest it may involve the patient's ability to dampen down pain signals travelling from the incision site to the brain.
Humans have an in-built system that produces opiates as well as other pain-relieving molecules in response to injury, e.g. surgery. However, this response varies hugely from person to person and may even be impacted by the psychological state of the individual at the time of surgery. Some of these pain modulating mechanisms can be measured before and after surgery in patients using sensory testing, a robust and established objective method to assess patients'.
Identifying patients who are most at risk of a persistent pain state will allow both academics and clinicians to investigate and better target appropriate treatments.
Undertaking these longitudinal observational assessments will facilitate an improved mechanistic insight of the transition from acute to pathological pain, with the ultimate goal of improving outcomes for patients'.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (over 18 years of age) undergoing elective repair of the thoraco-abdominal aorta. Able to adequately understand and respond to verbal instructions
Disqualifiers
Unwilling or unable to give consent, Age <18 years
Trial population
Adults Undergoing Elective Repair of the thoraco-abdominal aorta
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Characterise the sensory phenotype of Persistent Postsurgical Pain following Thoracoabdominal Aortic Surgery with Quantitative Sensory Testing as a change measure.
Quantitative Sensory Tests (Pre-op, Early Post-operative Period, \> 3 months Post-op)
Characterise the Pain Intensity as a change measure following Thoracoabdominal Aortic Surgery
Pain Intensity as measured by Visual Analogue Score (Pre-Op, Pre discharge, after three months post-op)
Characterise the Pain Intensity as a change measure following Thoracoabdominal Aortic Surgery
Pain Intensity as measured by Numerical Rating Score (Pre-Op, Throughout the peri-op period and till 2 years post-op)
Characterise the analgesia requirements as a change measure following Thoracoabdominal Aortic Surgery
Analgesic requirements as measured by oral morphine equivalents (Pre-Op, Throughout the peri-op period and till 2 years post-op)
Secondary outcomes
Determine the influence of baseline psychological and social profiles on postoperative pain outcomes.
Measured with Pain Catastrophising Scale (PCS) (Pre-Op, \> 3 months Post-op)
Determine the influence of baseline psychological and social profiles on postoperative pain outcomes.
Pain Anxiety Symptom Scale PASS20 as a change measure over time (Pre-Op, \> 3 months Post-op)
Determine the influence of baseline psychological and social profiles on postoperative pain outcomes.
Patient-Reported Outcomes Measurement Information System PROMIS: Fatigue and Sleep, depression and Anxiety as a change measure over time. (Pre-Op, \> 3 months Post-op)
Describe the impact of Persistent Post Surgical Pain on Quality of Life
Changes in EuroQual 5 Dimensions EQ5D. (Pre-Op, \> 3 months Post-op and till 2 years post-op)
Sponsors and contacts
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Queen Mary University of London
Lead sponsor
Barts & The London NHS Trust
Collaborator