Investigate and Predict Aortic & Thoracic Surgery Persistenet Postsurgical Pain

NCT05369130 | Recruiting

• 1 other identifier: 303825
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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'.

Conditions

Persistent Postsurgical Pain

Outcome Measures

Primary Outcomes (10)

• 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

Secondary Outcomes (4)

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

  3 years

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

  3 years

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

  3 years

• Describe the impact of Persistent Post Surgical Pain on Quality of Life

  3 years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults Undergoing Elective Repair of the thoraco-abdominal aorta

You may qualify if:

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

You may not qualify if:

• Unwilling or unable to give consent, Age \<18 years

Sponsors & Collaborators

• Queen Mary University of London: lead
• Barts & The London NHS Trust: collaborator

Study Sites (1)

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Acellular CSF and Plasma

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Sibtain Anwar, MBBS MA PhD

  Barts Health NHS Trust & Queen Mary University of London

  STUDY CHAIR

Central Study Contacts

Brian Herath, MBBS

CONTACT

00447870681640; b.herath@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: May 11, 2022
• Study Start: June 12, 2022
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

GB (1)