Clinical trial NCT05369130: Investigate and Predict Aortic & Thoracic Surgery Persistenet Postsurgical Pain
Official title: Characterising the Phenotype for Persistent Postoperative Pain Following Repair of the Thoraco-abdominal Aorta
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Persistent Postsurgical Pain
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: Barts & The London NHS Trust
First posted: 2022-05-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults Undergoing Elective Repair of the thoraco-abdominal aorta

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'.


Eligibility criteria: 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

Primary outcomes:
measure: Characterise the sensory phenotype of Persistent Postsurgical Pain following Thoracoabdominal Aortic Surgery with Quantitative Sensory Testing as a change measure.
timeFrame: 3 Years
measure: Characterise the Pain Intensity as a change measure following Thoracoabdominal Aortic Surgery
timeFrame: 3 years
measure: Characterise the Pain Intensity as a change measure following Thoracoabdominal Aortic Surgery
timeFrame: 3 years
measure: Characterise the analgesia requirements as a change measure following Thoracoabdominal Aortic Surgery
timeFrame: 3 years
measure: Characterise the analgesia requirements as a change measure following Thoracoabdominal Aortic Surgery
timeFrame: 3 years
measure: Characterise the presence of neuropathic sensory phenotype of patients undergoing Thoracoabdominal Aortic Surgery pre-op, post-op and > 3 months post-op.
timeFrame: 3 years
measure: Characterise the presence of neuropathic sensory phenotype of patients undergoing Thoracoabdominal Aortic Surgery pre-op, post-op and > 3 months post-op.
timeFrame: 3 years
measure: 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
timeFrame: 3 Years
measure: 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
timeFrame: 1 Week
measure: Identify Predictors of Persistent Postsurgical Pain following Thoracoabdominal Aorta surgery
timeFrame: 3 years
Secondary outcomes:
measure: Determine the influence of baseline psychological and social profiles on postoperative pain outcomes.
timeFrame: 3 years
measure: Determine the influence of baseline psychological and social profiles on postoperative pain outcomes.
timeFrame: 3 years
measure: Determine the influence of baseline psychological and social profiles on postoperative pain outcomes.
timeFrame: 3 years
measure: Describe the impact of Persistent Post Surgical Pain on Quality of Life
timeFrame: 3 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
Study officials:
affiliation: Barts Health NHS Trust & Queen Mary University of London
name: Sibtain Anwar, MBBS MA PhD
role: STUDY_CHAIR
References: