Investigate and Predict Aortic & Thoracic Surgery Persistenet Postsurgical Pain

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQueen Mary University of London

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Unwilling or unable to give consent, Age <18 years

Trial population

Adults Undergoing Elective Repair of the thoraco-abdominal aorta

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 2 trial groups
Group A: Develop Persistent Postsurgical Pain
Group B: Absence of Persistent Postsurgical Pain

Trial outcomes

Primary outcomes

1

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)

Time frame
3 Years
2

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)

Time frame
3 years
3

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)

Time frame
3 years
4

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)

Time frame
3 years

Secondary outcomes

1

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)

Time frame
3 years
2

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)

Time frame
3 years
3

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)

Time frame
3 years
4

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)

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Queen Mary University of London

Lead sponsor

Barts & The London NHS Trust

Collaborator