Correlation of Eicosanoid and Proresolving Lipid Mediator Temporal Profiles and Resolution of Pain After Thoracic Surgery

NCT03360175 | Unknown DMC

• 1 other identifier: 2017P002402
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the current pilot study is to investigate whether perioperative dysregulated systemic lipid mediator pathways (more specifically increased pro-inflammatory and decreased anti-inflammatory pathways) are associated with slower resolution of pain after surgery and increased risk for development of persistent postsurgical pain (PPSP). In addition, we will look for correlations between the pro-resolving lipid mediator profile and Quality of Recovery (QoR-15), duration of hospital stay, and frequency of complications, e.g. wound infections.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• time course of pain resolution after thoracic surgery

  12 months

Secondary Outcomes (2)

• incidence of persistent pain after thoracic surgery

  18 months

• Quality of Recovery after thoracic surgery

  12 months

Study Arms (1)

Thoracic Surgery Patients

Inclusion criteria include: Patients scheduled to undergo thoracic surgery at Brigham and Women's Hospital, between the ages 18-85 years old. Exclusion criteria are: pre-existing chronic pain or opioid use; current treatment with corticosteroids; evidence of active infection; chronic liver disease; end-stage renal disease (CKD-5); chronic inflammatory disorders; recent major surgery or illness within 30 days; use of immunosuppressive medication; history of organ transplantation. Pro-inflammatory eicosanoid and pro resolving lipid mediator temporal profiles will be determined pre-operatively, on post-operative day 1 and on post-operative day 14. In addition, daily pain scores will be recorded for 60 days after surgery and at 3, 6 and 12 months.

Other: No intervention - observational study

Interventions

No intervention - observational study OTHER

No intervention - observational study

Thoracic Surgery Patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo thoracic surgery at Brigham and Women's Hospital

You may qualify if:

• Age 18-85
• Patients scheduled to undergo thoracic surgery at Brigham and Women's Hospital

You may not qualify if:

• Pre-existing chronic pain or opioid use
• Current treatment with corticosteroids
• Evidence of active infection
• Chronic liver disease, end-stage renal disease (CKD-5), or chronic inflammatory disorders
• Recent major surgery or illness within 30 days
• Use of immunosuppressive medication
• History of organ transplantation.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be obtained for determination of pro-inflammatory/ pro resolving lipid mediator temporal profiles

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mieke A Soens, MD

CONTACT

617-732-8218; msoens@bwh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Staff Anesthesiologist

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 4, 2017
• Study Start: December 11, 2017
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 4, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share