NCT06023225

Sex Hormones, Postoperative Pain and Opioid Use

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 210 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 11 Years – 16 Years
• Healthy volunteers: —

Summary

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

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.

Conditions

• Postoperative Pain
• Opioid Use

Interventions

Type	Name	Description
BEHAVIORAL	Pain	Postoperative pain levels
BEHAVIORAL	Opioid use	Postoperative opioid use

Timeline

• Start date: 2023-09-01
• Primary completion: 2027-07-01
• Completion: 2029-07-01
• First posted: 2023-09-05
• Last updated: 2025-08-13

Locations

1 site across 1 country: United States