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Sex Hormones, Postoperative Pain and Opioid Use — SPO  

Postoperative Pain Clinical Trial

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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06023225
Study type Observational
Source Washington University School of Medicine
Contact
Status Recruiting
Phase
Start date September 1, 2023
Completion date July 1, 2027
View Details
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