Washington University School of Medicine
St Louis, Missouri, 63110, United States
Location status: Recruiting
Location contact
Alana McMichael, MA
CONTACT
Hadas Nahman-Averbuch, PhD
PRINCIPAL_INVESTIGATOR
Joel Brown
CONTACT
NCT Number: NCT06023225
Aim 1- To identify relationships between sex hormone levels and postoperative pain and opioid use.
Aim 2: To determine whether the effects of testosterone on postoperative pain and opioid use are mediated by immune factors
Interested in participating?
Request Info11 year–16 year
Female
Observational
St Louis, Missouri, 63110, United States
Location status: Recruiting
Alana McMichael, MA
CONTACT
Hadas Nahman-Averbuch, PhD
PRINCIPAL_INVESTIGATOR
Joel Brown
CONTACT
After signing the consent and assent forms, participants and their parents/guardians will complete several surveys, including demographic, behavioral, pain, substance use and analgesic risk assessment measures, and developmental surveys. In addition, a blood sample (for hormonal and immune analyses) will be collected on the day of the surgery and/or postoperative. Surgery-related parameters including postoperative pain, and opioid type and doses during the hospital time will be collected.
In addition, before or after the surgery, patients and their parents/guardians will be interviewed. The interview will include questions about the surgery and about potential future study assessing the efficacy of sex hormone treatment on opioid use.
Longitudinal measures. At routine follow-up with the surgeons or after 1 week, 1 month, 3 months, and 6 months, study staff will contact patients to inquire about persistent pain (location, severity), and persistent opioid use. Based on previous studies, we estimate that ∼30% will have persistent postoperative pain, and ∼5% will have persistent opioid use.After signing the consent and assent forms, participants and their parents/guardians will complete several surveys, including demographic, behavioral, pain, substance use and analgesic risk assessment measures, and developmental surveys. In addition, a blood sample (for hormonal and immune analyses) will be collected on the day of the surgery and/or postoperative. Surgery-related parameters including postoperative pain, and opioid type and doses during the hospital time will be collected.
In addition, before or after the surgery, patients and their parents/guardians will be interviewed. The interview will include questions about the surgery and about potential future study assessing the efficacy of sex hormone treatment on opioid use.
Longitudinal measures. At routine follow-up with the surgeons or after 1 week, 1 month, 3 months, and 6 months, study staff will contact patients to inquire about persistent pain (location, severity), and persistent opioid use. Based on previous studies, we estimate that ∼30% will have persistent postoperative pain, and ∼5% will have persistent opioid use.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Pediatric female patients between the ages 11-16 undergoing an orthopedic (trauma and non-trauma) surgical procedure involving a long bone or joint, or the spine, English speaking
Exclusion criteria
Pregnancy; Diagnosis of chronic pain, Psychiatric, developmental or neurological disorders, Disorders that are associated with pubertal maturation (e.g., precocious puberty).
Postoperative pain levels
Postoperative opioid use
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Time frame: Baseline
Immune factors
Washington University School of Medicine
Other
Relationship Between Sex Hormones, Postoperative Pain and Opioid Use: the Role of Immune Factors
Acronym: SPO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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