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Investigate and Predict Aortic & Thoracic Surgery Persistenet Postsurgical Pain

Characterising the Phenotype for Persistent Postoperative Pain Following Repair of the Thoraco-abdominal Aorta

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05369130
Acronym
ImPARTonPPP
Enrollment
60
Registered
2022-05-11
Start date
2022-06-12
Completion date
2029-02-01
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Postsurgical Pain

Brief summary

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'.

Interventions

None listed

Sponsors

Queen Mary University of London
Lead SponsorOTHER
Barts & The London NHS Trust
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults (over 18 years of age) undergoing elective repair of the thoraco-abdominal aorta. Able to adequately understand and respond to verbal instructions

Exclusion criteria

* Unwilling or unable to give consent, Age \<18 years

Design outcomes

Primary

MeasureTime frameDescription
Characterise the sensory phenotype of Persistent Postsurgical Pain following Thoracoabdominal Aortic Surgery with Quantitative Sensory Testing as a change measure.3 YearsQuantitative Sensory Tests (Pre-op, Early Post-operative Period, \> 3 months Post-op)
Characterise the Pain Intensity as a change measure following Thoracoabdominal Aortic Surgery3 yearsPain Intensity as measured by Visual Analogue Score (Pre-Op, Pre discharge, after three months post-op)
Characterise the analgesia requirements as a change measure following Thoracoabdominal Aortic Surgery3 yearsAnalgesic requirements as measured by oral morphine equivalents (Pre-Op, Throughout the peri-op period and till 2 years post-op)
Characterise the presence of neuropathic sensory phenotype of patients undergoing Thoracoabdominal Aortic Surgery pre-op, post-op and > 3 months post-op.3 yearsNeuropathic Pain as defined by Douleur Neuropathique 4 (DN4) (Pre-Op, \> 3 months Post-op and till 2 years post-op)
Characterise the change in biochemical phenotype pre-op and in the early post-op period following Thoracoabdominal Aortic Surgery and define significant differences between those with and without persistent post surgical pain3 YearsMulti regression analysis of CSF composition.
Identify Predictors of Persistent Postsurgical Pain following Thoracoabdominal Aorta surgery3 yearsDetermine 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.

Secondary

MeasureTime frameDescription
Determine the influence of baseline psychological and social profiles on postoperative pain outcomes.3 yearsMeasured with Pain Catastrophising Scale (PCS) (Pre-Op, \> 3 months Post-op)
Describe the impact of Persistent Post Surgical Pain on Quality of Life3 yearsChanges in EuroQual 5 Dimensions EQ5D. (Pre-Op, \> 3 months Post-op and till 2 years post-op)

Countries

United Kingdom

Contacts

CONTACTBrian Herath, MBBS
b.herath@nhs.net00447870681640
STUDY_CHAIRSibtain Anwar, MBBS MA PhD

Barts Health NHS Trust & Queen Mary University of London

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026