Pain, PostoperativeNCT03360175
Correlation of Eicosanoid and Proresolving Lipid Mediator Temporal Profiles and Resolution of Pain After Thoracic Surgery
An observational study of Pain, Postoperative, run by Brigham and Women's Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain, Postoperative
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 11 Dec 2017to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to undergo thoracic surgery at Brigham and Women's Hospital
Who may be able to join
- Age 18-85
- Patients scheduled to undergo thoracic surgery at Brigham and Women's Hospital
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
This is a prospective, observational pilot study that will assess whether 1) a peri-operative dysregulated metabolo-lipidomics or SPM profile is associated with slower resolution of pain after surgery and an increased risk for development of persistent postsurgical pain (PPSP), and 2) whether a peri-operative dysregulated metabolo-lipidomics profile correlates with low Quality of Recovery (QoR-15) scores, duration of hospital stay and frequency of complications, e.g. wound infection.
The study will address the following Specific Aims:
Specific Aim 1: To determine the correlation between the perioperative eicosanoid and pro-resolving lipid mediator temporal profile and day-to-day resolution of pain after thoracic surgery.
We hypothesize that patients who have slower resolution of pain after thoracic surgery have dysregulated systemic lipid mediator pathways when compared to those patients who have faster resolution of pain.
Specific Aim 2: To determine the effectiveness of perioperative SPM signature as a novel predictive marker for the development of persistent pain after surgery (PPSP).
We hypothesize that patients with dysregulated systemic lipid mediator pathways, more specifically up-regulated pro-inflammatory lipid mediator pathways and down-regulated pro-resolving lipid mediator pathways, are more likely to develop PPSP.
Specific Aim 3: To determine the correlation between the perioperative eicosanoid and pro-resolving lipid mediator temporal profile and quality of recovery after surgery, duration of hospital stay and complications.
We hypothesize that dysregulated lipid mediator profiles are associated with a decreased Quality of Recovery Score (QoR-15), prolonged hospital stay and increased rates of complications, such as problems with wound healing and infection.
- Conditions
- Pain, Postoperative
- Being tested
- No intervention - observational study
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - observational studyOther
No intervention - observational study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention - observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
time course of pain resolution after thoracic surgery
Measured: 12 months
Secondary outcomes (2)
incidence of persistent pain after thoracic surgery
Measured: 18 months
Quality of Recovery after thoracic surgery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start11 Dec 2017 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mieke A. Soens, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360175
- Sponsor's protocol ID
- 2017P002402
- Status last verified
- Nov 2017
- First submitted
- 28 Nov 2017
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Eicosanoid and Proresolving Lipid Mediator Temporal Profiles and Resolution of Pain After Thoracic Surgery
- ClinicalTrials.gov ID
- NCT03360175
- Acronym / sponsor ID
- 2017P002402
- Conditions
- Pain, Postoperative
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 11 Dec 2017 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 4 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, observational pilot study that will assess whether 1) a peri-operative dysregulated metabolo-lipidomics or SPM profile is associated with slower resolution of pain after surgery and an increased risk for development of persistent postsurgical pain (PPSP), and 2) whether a peri-operative dysregulated metabolo-lipidomics profile correlates with low Quality of Recovery (QoR-15) scores, duration of hospital stay and frequency of complications, e.g. wound infection.
The study will address the following Specific Aims:
Specific Aim 1: To determine the correlation between the perioperative eicosanoid and pro-resolving lipid mediator temporal profile and day-to-day resolution of pain after thoracic surgery.
We hypothesize that patients who have slower resolution of pain after thoracic surgery have dysregulated systemic lipid mediator pathways when compared to those patients who have faster resolution of pain.
Specific Aim 2: To determine the effectiveness of perioperative SPM signature as a novel predictive marker for the development of persistent pain after surgery (PPSP).
We hypothesize that patients with dysregulated systemic lipid mediator pathways, more specifically up-regulated pro-inflammatory lipid mediator pathways and down-regulated pro-resolving lipid mediator pathways, are more likely to develop PPSP.
Specific Aim 3: To determine the correlation between the perioperative eicosanoid and pro-resolving lipid mediator temporal profile and quality of recovery after surgery, duration of hospital stay and complications.
We hypothesize that dysregulated lipid mediator profiles are associated with a decreased Quality of Recovery Score (QoR-15), prolonged hospital stay and increased rates of complications, such as problems with wound healing and infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracic Surgery Patients | – | Other: No intervention - observational studyInclusion 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo thoracic surgery at Brigham and Women's Hospital
Key inclusion criteria (2 listed)
- Age 18-85
- Patients scheduled to undergo thoracic surgery at Brigham and Women's Hospital
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention - observational studyNo intervention - observational study | Other | Thoracic Surgery Patients |
Primary outcome
time course of pain resolution after thoracic surgery
Time frame: 12 months
2 secondary outcomes
incidence of persistent pain after thoracic surgery
Time frame: 18 months
Quality of Recovery after thoracic surgery
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mieke A Soens, MD (617-732-8218, msoens@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time course of pain resolution after thoracic surgery (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2017.