Examining the link between sex hormones, pain after surgery, and opioid use
Relationship Between Sex Hormones, Postoperative Pain and Opioid Use: the Role of Immune Factors
This study is trying to see if levels of sex hormones like testosterone affect pain and opioid use in young girls aged 11-16 after they have orthopedic surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 210 (estimated) |
| Ages | 11 Years to 16 Years |
| Sex | Female |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT06023225 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationships between sex hormone levels and postoperative pain as well as opioid use in pediatric female patients aged 11-16 undergoing orthopedic surgeries. Participants will complete various surveys regarding demographics, pain, and substance use, and provide blood samples for hormonal and immune analysis. Data on postoperative pain and opioid use will be collected during the hospital stay and through follow-up interviews at multiple intervals post-surgery. The study seeks to understand if testosterone affects pain and opioid use through immune factors.
Who should consider this trial
Good fit: Ideal candidates are English-speaking female patients aged 11-16 who are undergoing orthopedic surgical procedures involving long bones or joints, or the spine.
Not a fit: Patients who are pregnant, have chronic pain, or have psychiatric, developmental, or neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies and reduced opioid use in pediatric patients after surgery.
How similar studies have performed: Previous studies have indicated potential relationships between sex hormones and pain management, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.