Postoperative and Chronic Pain Genetic Spine Surgery Study



Status:Enrolling by invitation
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:10 - 18
Updated:11/3/2018
Start Date:December 2016
End Date:December 2020

Use our guide to learn which trials are right for you!

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.

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.

Inclusion Criteria:

1. Children aged 10 to 18, inclusive, years of age

2. Diagnosis of Idiopathic scoliosis, kyphosis and/or kyphoscoliosis

3. Scheduled for spine fusion.

Exclusion Criteria:

1. Patients on chronic pain medication (opioid use over 6 months prior to surgery)

2. Pregnant or breastfeeding females.

3. Children with a history of or active renal or liver disease.

4. Non-English speaking patients.

5. Developmental delay

6. Body Mass Index ≥ 30

7. Currently taking tricyclic, selective serotonin reuptake inhibitor (SSRI),
serotonin-norepinephrine reuptake inhibitor (SNRI) class of medications (within the
last month)

8. 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.

9. Severe lung disease such as cystic fibrosis, pulmonary fibrosis, pneumonia within the
last month

10. History of seizures currently treated on medication (patients off medication and
seizure free for greater than one year may be included)

11. Other known genetic diseases including but not limited to Ehlers Danlos, Downs' etc.

12. History of Obstructive sleep apnea by history (pauses during sleep, significant
snoring, use of CPAP)
We found this trial at
3
sites
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials