Sex Hormones, Postoperative Pain and Opioid Use

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Relationship Between Sex Hormones, Postoperative Pain and Opioid Use: the Role of Immune Factors

Conditions
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Postoperative Pain, Opioid Use

Intervention / Treatment
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* Behavioral: Pain
* Behavioral: Opioid use


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Postoperative patients<br>Pediatric female patients undergoing a surgical procedure | Behavioral: Pain<br>* Postoperative pain levels<br>Behavioral: Opioid use<br>* Postoperative opioid use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sex hormone level of Testosterone |  | Baseline | 
| Sex hormone level of estrogen |  | Baseline | 
| Sex hormone level of progesterone |  | Baseline | 
| Levels of IL-10 and IL-6 | Immune factors | Baseline |