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NCT Number: NCT06023225

Sex Hormones, Postoperative Pain and Opioid Use

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

Recruiting

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Key information

Age range

11 year–16 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

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).

Treatment and study plan

Pain

Behavioral

Postoperative pain levels

Opioid use

Behavioral

Postoperative opioid use

Primary outcomes

  1. Sex hormone level of Testosterone

    Time frame: Baseline

  2. Sex hormone level of estrogen

    Time frame: Baseline

  3. Sex hormone level of progesterone

    Time frame: Baseline

  4. Levels of IL-10 and IL-6

    Time frame: Baseline

    Immune factors

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Acronym: SPO

Important dates

Study start
2023
Primary completion
2027
Study completion
2029
First posted
Sep 5, 2023
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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