Persistent Postsurgical PainImPARTonPPPNCT05369130
Investigate and Predict Aortic & Thoracic Surgery Persistenet Postsurgical Pain
An observational study of Persistent Postsurgical Pain, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Postsurgical Pain
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jun 2022to Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults Undergoing Elective Repair of the thoraco-abdominal aorta
Who may be able to join
- Adults (over 18 years of age) undergoing elective repair of the thoraco-abdominal aorta. Able to adequately understand and respond to verbal instructions
Who cannot join
- Unwilling or unable to give consent, Age <18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
St Bartholomew's Hospital
London, EC1A 7BE
Brian Herath, MBBS, b.herath@nhs.net
Sibtain Anwar, s.anwar@qmul.ac.uk
About this study
Official title: Characterising the Phenotype for Persistent Postoperative Pain Following Repair of the Thoraco-abdominal Aorta
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.
Read more
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'.
- Conditions
- Persistent Postsurgical Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Develop Persistent Postsurgical Pain | Pain present 3 months post-op related to the surgical operation | |
| Absence of Persistent Postsurgical Pain | Resolution of post-operative pain within the first three months of the operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 Years
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)
Measured: 3 years
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)
Measured: 3 years
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)
Measured: 3 years
Characterise the analgesia requirements as a change measure following Thoracoabdominal Aortic Surgery
Non-opioid analgesic prescriptions (Pre-Op, Throughout the peri-op period and till 2 years post-op)
Measured: 3 years
Characterise the presence of neuropathic sensory phenotype of patients undergoing Thoracoabdominal Aortic Surgery pre-op, post-op and > 3 months post-op.
Neuropathic Pain as defined by Douleur Neuropathique 4 (DN4) (Pre-Op, > 3 months Post-op and till 2 years post-op)
Measured: 3 years
Characterise the presence of neuropathic sensory phenotype of patients undergoing Thoracoabdominal Aortic Surgery pre-op, post-op and > 3 months post-op.
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)
Measured: 3 years
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
Multi regression analysis of CSF composition.
Measured: 3 Years
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
Multi regression analysis of blood composition.
Measured: 1 Week
Identify Predictors of Persistent Postsurgical Pain following Thoracoabdominal Aorta surgery
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.
Measured: 3 years
Secondary outcomes (4)
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)
Measured: 3 years
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)
Measured: 3 years
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)
Measured: 3 years
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)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start12 Jun 2022
- Primary completion31 Jan 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Postsurgical PainStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Barts & The London NHS Trust
- Responsible party
- Sponsor
- Investigators
- Sibtain Anwar, MBBS MA PhD, Study chair, Barts Health NHS Trust & Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369130
- Sponsor's protocol ID
- 303825
- Acronym
- ImPARTonPPP
- Status last verified
- Mar 2026
- First submitted
- 22 Feb 2022
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised data will be made available
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterising the Phenotype for Persistent Postoperative Pain Following Repair of the Thoraco-abdominal Aorta
- ClinicalTrials.gov ID
- NCT05369130
- Acronym / sponsor ID
- ImPARTonPPP / 303825
- Conditions
- Persistent Postsurgical Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Barts & The London NHS Trust
- Study start
- 12 Jun 2022 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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'.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Develop Persistent Postsurgical Pain | – | –Pain present 3 months post-op related to the surgical operation |
| Absence of Persistent Postsurgical Pain | – | –Resolution of post-operative pain within the first three months of the operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults Undergoing Elective Repair of the thoraco-abdominal aorta
Key inclusion criteria (1 listed)
- Adults (over 18 years of age) undergoing elective repair of the thoraco-abdominal aorta. Able to adequately understand and respond to verbal instructions
Key exclusion criteria (1 listed)
- Unwilling or unable to give consent, Age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
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)
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)
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)
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)
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)
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.
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.
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.
4 secondary outcomes
Determine the influence of baseline psychological and social profiles on postoperative pain outcomes.
Time frame: 3 years
Determine the influence of baseline psychological and social profiles on postoperative pain outcomes.
Time frame: 3 years
Determine the influence of baseline psychological and social profiles on postoperative pain outcomes.
Time frame: 3 years
Describe the impact of Persistent Post Surgical Pain on Quality of Life
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Undecided. Anonymised data will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sibtain Anwar, MBBS MA PhD study chair
Barts Health NHS Trust & Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Postsurgical Pain, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Herath, MBBS (00447870681640, b.herath@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterise the sensory phenotype of Persistent Postsurgical Pain following Thoracoabdominal Aortic Surgery with Quantitative Sensory Testing as a change measure. (time frame: 3 Years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.