Chronic Post-surgical PainNCT04681183
Pilot Study Evaluating Neuro-Imaging Correlates of Epigenetic Finding in Prediction of Chronic Postsurgical Pain
An observational study of Chronic Post-surgical Pain, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
This pilot research study is being performed to learn more about pain and look at how pain changes brain chemistry and function. The research team would like to learn new information to better control chronic pain after surgery. This information collected in this research will be used to plan possible future visits. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Chronic Post-surgical Pain
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2020to 1 Dec 2024
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing chest surgery (thoracotomy, thoracoscopy, Nuss procedure, pectus surgery, mastectomy), spine surgery, amputation, hernia repair or hip/knee replacement in the hospital.
Who may be able to join
- Male or female aged ≥ 8 yrs of age
- English speaking;
- Healthy (Defined as American Society of Anesthesiologists Physical Status 1 or 2)
- Ability to provide assent/consent/parent permission.
- Scheduled to undergo chest surgery (thoracotomy, thoracoscopy, Nuss procedure, pectus surgery, mastectomy), spine surgery, amputation, hernia repair or hip/knee replacement.
Who cannot join
- History of chronic pain conditions including migraines
- Use of opioids chronically or for major surgery within the 6 months prior to enrollment
- Severe obesity (BMI>35 kg/m2)
- Taking no more than two concomitant medications known to induce or inhibit CYP2D6 activity, including paroxetine, fluoxetine, cimetidine, and duloxetine or other medications used to treat attention deficit hyperactivity disorder (medications containing amphetamine or methylphenidate).
- Use of hormonal contraceptives
- Use of medications that may alter pain sensitivity (e.g. gabapentin,/pregabalin amitryptiline/other antidepressants, clonidine).
Show all 13Show fewer
- Active or history of renal/liver problems or congenital cardiac disease
- Diagnosed developmental delay
- Pregnant or lactating females
- Any skin condition that prevents cuff application
- History of seizures
- Claustrophobia
- Metallic implants/orthodontics/braces or other MRI exclusion (MRI safety screening will be conducted prior to enrollment and prior to each MRI scan)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
About this study
This pilot research study is being performed to learn more about pain and look at how pain changes brain chemistry and function. The research team would like to learn new information to better control chronic pain after surgery. This information collected in this research will be used to plan possible future visits. Participants in this study are being asked to participate because they are scheduled for an upcoming surgery. The research team would like to observe them before and after their surgery.
Read the detailed description
This study is a pilot feasibility study in 30 healthy, preoperative children and young adults undergoing major surgery with high risk for chronic post-surgical pain (CPSP) to characterize the brain metabolite status of the Anterior cingulate cortices (ACC) and insula in pre-surgical adolescents and to understand the relationship between metabolite levels and CPSP. The investigators will also examine whether neurochemical tone in these regions is related to resting state functional connectivity with other brain regions. Correlations between differentially methylated CpG sites in genes enriching gamma aminobutyric acid (GABA) and Dopamine-DARPP-32 pathways and Glu/GABA levels in insula/ACC will be analyzed.
- Conditions
- Chronic Post-surgical Pain
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic post-surgical pain; Unabbreviated scale title "Chronic post-surgical pain scores"
Pain scores over prior 2 weeks reported 2-6 months after surgery; minimum value = 0, maximum value = 10; higher score means more severe pain
Measured: 2-6 months after surgery
Secondary outcomes (3)
Evoked pressure pain measures; Unabbreviated scale title "Evoked pressure pain measures"
Average of 3 measurements taken using a hand-held algometer; minimum value = 0, maximum value = None; higher measurement means better pain tolerance
Measured: 1-2 weeks after surgery
Resting state connectivity
Pressure cuff measurements while undergoing MRI scan
Measured: 1 - 8 weeks before surgery
Correlation of DNAm of specified gene regions with outcomes
Differential DNAm measured by array/sequencing
Measured: 1-8 weeks before surgery or day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start14 Dec 2020
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Post-surgical PainStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vidya Chidambaran, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681183
- Sponsor's protocol ID
- 2020-0277
- Status last verified
- Mar 2024
- First submitted
- 18 Dec 2020
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating Neuro-Imaging Correlates of Epigenetic Finding in Prediction of Chronic Postsurgical Pain
- ClinicalTrials.gov ID
- NCT04681183
- Acronym / sponsor ID
- 2020-0277
- Conditions
- Chronic Post-surgical Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 23 Dec 2020 (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.
This pilot research study is being performed to learn more about pain and look at how pain changes brain chemistry and function. The research team would like to learn new information to better control chronic pain after surgery. This information collected in this research will be used to plan possible future visits. Participants in this study are being asked to participate because they are scheduled for an upcoming surgery. The research team would like to observe them before and after their surgery.
Detailed description
This study is a pilot feasibility study in 30 healthy, preoperative children and young adults undergoing major surgery with high risk for chronic post-surgical pain (CPSP) to characterize the brain metabolite status of the Anterior cingulate cortices (ACC) and insula in pre-surgical adolescents and to understand the relationship between metabolite levels and CPSP. The investigators will also examine whether neurochemical tone in these regions is related to resting state functional connectivity with other brain regions. Correlations between differentially methylated CpG sites in genes enriching gamma aminobutyric acid (GABA) and Dopamine-DARPP-32 pathways and Glu/GABA levels in insula/ACC will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing chest surgery (thoracotomy, thoracoscopy, Nuss procedure, pectus surgery, mastectomy), spine surgery, amputation, hernia repair or hip/knee replacement in the hospital.
Key inclusion criteria (5 listed)
- Male or female aged ≥ 8 yrs of age
- English speaking;
- Healthy (Defined as American Society of Anesthesiologists Physical Status 1 or 2)
- Ability to provide assent/consent/parent permission.
- Scheduled to undergo chest surgery (thoracotomy, thoracoscopy, Nuss procedure, pectus surgery, mastectomy), spine surgery, amputation, hernia repair or hip/knee replacement.
Key exclusion criteria (13 listed)
- History of chronic pain conditions including migraines
- Use of opioids chronically or for major surgery within the 6 months prior to enrollment
- Severe obesity (BMI>35 kg/m2)
- Taking no more than two concomitant medications known to induce or inhibit CYP2D6 activity, including paroxetine, fluoxetine, cimetidine, and duloxetine or other medications used to treat attention deficit hyperactivity disorder (medications containing amphetamine or methylphenidate).
- Use of hormonal contraceptives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chronic post-surgical pain; Unabbreviated scale title "Chronic post-surgical pain scores"
Time frame: 2-6 months after surgery
Pain scores over prior 2 weeks reported 2-6 months after surgery; minimum value = 0, maximum value = 10; higher score means more severe pain
3 secondary outcomes
Evoked pressure pain measures; Unabbreviated scale title "Evoked pressure pain measures"
Time frame: 1-2 weeks after surgery
Resting state connectivity
Time frame: 1 - 8 weeks before surgery
Correlation of DNAm of specified gene regions with outcomes
Time frame: 1-8 weeks before surgery or day of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
Related trials for Chronic Post-surgical Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
Recruiting
Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
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.
Vidya Chidambaran, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Post-surgical Pain, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 5 inclusion and 13 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 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic post-surgical pain; Unabbreviated scale title "Chronic post-surgical pain scores" (time frame: 2-6 months after surgery). 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 13 Mar 2024.