- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02998138
Postoperative and Chronic Pain Genetic Spine Surgery Study
July 31, 2023 updated by: Children's Hospital Medical Center, Cincinnati
A Multi-center Study of Genomic and Psychological Factors Affecting Postoperative and Chronic Pain in Children Undergoing Invasive (Spine) Surgery
This will be an open label, prospective study to determine the association between specific genotypes, epigenetics and behavioral factors, with the phenotypes, defined by pain perception, postoperative pain, analgesic and side effect responses to perioperative opioids, chronic postoperative pain and gene expression in adolescents following major spine surgery.
Study Overview
Status
Enrolling by invitation
Conditions
Detailed Description
Safe and effective analgesia is an important unmet medical need in children.
Despite efforts to promote non-pharmacologic interventions, drug treatment remains the standard of care for children experiencing severe pain following surgery.
Inadequate pain relief after invasive surgery, and side effects from analgesics such as morphine occur frequently in up to 50% of children.
A study of patient controlled analgesia (PCA) morphine use after spine surgery in adolescents observed a 45% incidence of postoperative nausea and vomiting and 7% incidence of respiratory depression.
Presently, evidence-based dosing guidelines for opioid therapy have not been ascertained in the pediatric patient population, and remains a trial and error method.
Despite aggressive pain management after spine surgery, findings showed that neither children's pain nor their analgesic use diminished significantly over time.
As such, there is a critical knowledge gap in the medical literature that significantly impacts the pediatric pain management.
Moreover, chronic postsurgical pain (CPSP, defined as pain attributable to the surgical procedure lasting for more than 2 months after surgery critically impacts 13-30% of children having surgery, and leads to chronic pain as adults imposing extraordinary annual costs on the health care system ($560-635 billion).
It has been recently shown that pain unpleasantness predicts the transition from acute to moderate/severe persistent post-surgical pain, whereas anxiety sensitivity predicts the maintenance of moderate/severe post-surgical pain from 6 to 12 months after surgery.
Spine fusion in adolescents is a particularly painful surgery with 15% incidence of pain even 5 years after surgery, and hence will serve as a good surgical model to evaluate the behavioral and genetic predictors of chronic postoperative pain.
In recognition of this therapeutic challenge the investigators plan to evaluate the determinants of inter-individual differences in opioid analgesic responsiveness, adverse effects, pain perception and predictors of chronic postoperative pain in children.
Study Type
Observational
Enrollment (Estimated)
880
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University Hospital
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins Hospital
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Children's Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- The Children's Hospital of Philadelphia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The investigators will recruit a total of 200 subjects over the study period to acquire the data necessary to derive a predictive model matching phenotype to genotype.
They will be recruited from the population of children ages 10 to 18, inclusive, years scheduled for spinal surgical procedures.
Description
Inclusion Criteria:
- Children aged 10 to 18, inclusive, years of age
- Diagnosis of Idiopathic scoliosis, kyphosis and/or kyphoscoliosis
- Scheduled for spine fusion.
Exclusion Criteria:
- Patients on chronic pain medication (opioid use over 6 months prior to surgery)
- Pregnant or breastfeeding females.
- Children with a history of or active renal or liver disease.
- Non-English speaking patients.
- Developmental delay
- Body Mass Index ≥ 30
- Currently taking tricyclic, selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI) class of medications (within the last month)
- Cardiac conditions including, but not limited to, cyanotic heart disease, Hypoplastic Left Ventricle, arrhythmia, hypertension with ongoing treatment, Kawasaki Disease, cardiomyopathies. Patients with asymptomatic valvular lesions or defects may be included.
- Severe lung disease such as cystic fibrosis, pulmonary fibrosis, pneumonia within the last month
- History of seizures currently treated on medication (patients off medication and seizure free for greater than one year may be included)
- Other known genetic diseases including but not limited to Ehlers Danlos, Downs' etc.
- History of Obstructive sleep apnea by history (pauses during sleep, significant snoring, use of CPAP)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric rating scale (NRS) pain scores
Time Frame: Data will be collected for 48 hours postoperatively
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Data will be collected for 48 hours postoperatively
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Occurrences of respiratory depression
Time Frame: Data will be collected for 48 hours postoperatively
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Respiratory rate (RR) <10 on POD 1 and 2
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Data will be collected for 48 hours postoperatively
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Occurrences of post-operative nausea/vomiting (PONV)
Time Frame: Data will be collected for 48 hours postoperatively
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Data will be collected for 48 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of morphine (or equivalent) used by patient
Time Frame: Data will be collected for 48 hours postoperative
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Data will be collected for 48 hours postoperative
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Chronic pain postoperatively
Time Frame: 2 - 6 months postoperatively
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Participants will complete questionnaires regarding pain since surgery was completed
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2 - 6 months postoperatively
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Persistent pain postoperatively
Time Frame: 10 - 12 months postoperatively
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Participants will complete questionnaires regarding pain since surgery was completed
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10 - 12 months postoperatively
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Opioid addiction by history on follow-up
Time Frame: 1 year postoperatively
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1 year postoperatively
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Vidya Chidambaran, MD, Children's Hospital Medical Center, Cincinnati
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
March 7, 2016
First Submitted That Met QC Criteria
December 15, 2016
First Posted (Estimated)
December 20, 2016
Study Record Updates
Last Update Posted (Actual)
August 1, 2023
Last Update Submitted That Met QC Criteria
July 31, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-8339
- 2015-8633 (Other Identifier: CCHMC IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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