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NCT Number: NCT05369130

Investigate and Predict Aortic & Thoracic Surgery Persistenet Postsurgical Pain

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'.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location status: Recruiting

Location contact

Brian Herath, MBBS

CONTACT

[email protected]

Sibtain Anwar

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Characterise the sensory phenotype of Persistent Postsurgical Pain following Thoracoabdominal Aortic Surgery with Quantitative Sensory Testing as a change measure.

    Time frame: 3 Years

    Quantitative Sensory Tests (Pre-op, Early Post-operative Period, > 3 months Post-op)

  2. Characterise the Pain Intensity as a change measure following Thoracoabdominal Aortic Surgery

    Time frame: 3 years

    Pain Intensity as measured by Visual Analogue Score (Pre-Op, Pre discharge, after three months post-op)

  3. Characterise the Pain Intensity as a change measure following Thoracoabdominal Aortic Surgery

    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)

  4. Characterise the analgesia requirements as a change measure following Thoracoabdominal Aortic Surgery

    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)

  5. Characterise the analgesia requirements as a change measure following Thoracoabdominal Aortic Surgery

    Time frame: 3 years

    Non-opioid analgesic prescriptions (Pre-Op, Throughout the peri-op period and till 2 years post-op)

  6. Characterise the presence of neuropathic sensory phenotype of patients undergoing Thoracoabdominal Aortic Surgery pre-op, post-op and > 3 months 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)

  7. Characterise the presence of neuropathic sensory phenotype of patients undergoing Thoracoabdominal Aortic Surgery pre-op, post-op and > 3 months 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)

  8. 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 pain

    Time frame: 3 Years

    Multi regression analysis of CSF composition.

  9. 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 pain

    Time frame: 1 Week

    Multi regression analysis of blood composition.

  10. Identify Predictors of Persistent Postsurgical Pain following Thoracoabdominal Aorta surgery

    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.

Secondary outcomes

  1. Determine the influence of baseline psychological and social profiles on postoperative pain outcomes.

    Time frame: 3 years

    Measured with Pain Catastrophising Scale (PCS) (Pre-Op, > 3 months Post-op)

  2. Determine the influence of baseline psychological and social profiles on postoperative pain outcomes.

    Time frame: 3 years

    Pain Anxiety Symptom Scale PASS20 as a change measure over time (Pre-Op, > 3 months Post-op)

  3. Determine the influence of baseline psychological and social profiles on postoperative pain outcomes.

    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)

  4. Describe the impact of Persistent Post Surgical Pain on Quality of Life

    Time frame: 3 years

    Changes in EuroQual 5 Dimensions EQ5D. (Pre-Op, > 3 months Post-op and till 2 years post-op)

Study contacts

Contact information is provided by the study sponsor or research team.

Brian Herath, MBBS

CONTACT

[email protected]

00447870681640

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Collaborators

  • Barts & The London NHS Trust

Registry information

Official study title

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

Acronym: ImPARTonPPP

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
May 11, 2022
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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