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Clinical Trial NCT05369130 (ImPARTonPPP) for Persistent Postsurgical Pain is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Queen Mary University of LondonInvestigate and Predict Aortic & Thoracic Surgery Persistenet Postsurgical Pain (ImPARTonPPP) 60 Observational Academic-Led
Clinical Trial NCT05369130 (ImPARTonPPP) is an observational study for Persistent Postsurgical Pain that is recruiting. It started on 12 June 2022 with plans to enroll 60 participants. Led by Queen Mary University of London, it is expected to complete by 1 February 2029. The latest data from ClinicalTrials.gov was last updated on 16 March 2026.
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 fo...
Show MoreOfficial Title
Characterising the Phenotype for Persistent Postoperative Pain Following Repair of the Thoraco-abdominal Aorta
Conditions
Persistent Postsurgical PainOther Study IDs
- ImPARTonPPP
- 303825
NCT ID Number
Start Date (Actual)
2022-06-12
Last Update Posted
2026-03-16
Completion Date (Estimated)
2029-02
Enrollment (Estimated)
60
Study Type
Observational
Status
Recruiting
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Develop Persistent Postsurgical Pain Pain present 3 months post-op related to the surgical operation | N/A |
Absence of Persistent Postsurgical Pain Resolution of post-operative pain within the first three months of the operation | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) | 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) | 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) | 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) | 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) | 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) | 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) | 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. | 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. | 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. | 3 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) | 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) | 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) | 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) | 3 years |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Adults (over 18 years of age) undergoing elective repair of the thoraco-abdominal aorta. Able to adequately understand and respond to verbal instructions
- Unwilling or unable to give consent, Age <18 years
Queen Mary University of London103 active studies to exploreBarts & The London NHS TrustStudy Central Contact
Contact: Brian Herath, MBBS, 00447870681640, [email protected]
1 Study Locations in 1 Countries
St Bartholomew's Hospital, London, EC1A 7BE, United Kingdom
Brian Herath, MBBS, Contact, [email protected]
Sibtain Anwar, Contact, [email protected]
Recruiting