St Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
Location status: Recruiting
NCT Number: NCT05369130
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'.
Interested in participating?
Request Info18 year and older
All sexes
Observational
London, EC1A 7BE, United Kingdom
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 Years
Quantitative Sensory Tests (Pre-op, Early Post-operative Period, > 3 months Post-op)
Time frame: 3 years
Pain Intensity as measured by Visual Analogue Score (Pre-Op, Pre discharge, after three months post-op)
Time frame: 3 years
Pain Intensity as measured by Numerical Rating Score (Pre-Op, Throughout the peri-op period and till 2 years post-op)
Time frame: 3 years
Analgesic requirements as measured by oral morphine equivalents (Pre-Op, Throughout the peri-op period and till 2 years post-op)
Time frame: 3 years
Non-opioid analgesic prescriptions (Pre-Op, Throughout the peri-op period and till 2 years post-op)
Time frame: 3 years
Neuropathic Pain as defined by Douleur Neuropathique 4 (DN4) (Pre-Op, > 3 months Post-op and till 2 years post-op)
Time frame: 3 years
Neuropathic Pain as defined by Self Reported Leeds Assessment of Neuropathic Symptoms and Signs (SLANSS) (Pre-Op, > 3 months Post-op and till 2 years post-op)
Time frame: 3 Years
Multi regression analysis of CSF composition.
Time frame: 1 Week
Multi regression analysis of blood composition.
Time frame: 3 years
Determine if a composite biomarker or non response to conditioned pain modulation is a biomarker for development of persistent post-surgical pain and whether these are associated with biochemical differences through a bioinformatic data analysis approach.
Time frame: 3 years
Measured with Pain Catastrophising Scale (PCS) (Pre-Op, > 3 months Post-op)
Time frame: 3 years
Pain Anxiety Symptom Scale PASS20 as a change measure over time (Pre-Op, > 3 months Post-op)
Time frame: 3 years
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)
Time frame: 3 years
Changes in EuroQual 5 Dimensions EQ5D. (Pre-Op, > 3 months Post-op and till 2 years post-op)
Contact information is provided by the study sponsor or research team.
Queen Mary University of London
Other
Characterising the Phenotype for Persistent Postoperative Pain Following Repair of the Thoraco-abdominal Aorta
Acronym: ImPARTonPPP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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