Recruiting

Sex Hormones

Sponsor:

Washington University School of Medicine

Code:

NCT06023225

Conditions

Postoperative Pain

Opioid Use

Eligibility Criteria

Sex: Female

Age: 11 - 16

Healthy Volunteers: Not accepted

Interventions

Pain

Opioid use

Study Details

Brief 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

Conditions

Postoperative Pain

Opioid Use

Study ID

NCT06023225

Start date

Sep 1, 2023

Status verified date

Jul, 2026

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 11 - 16

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

210 participants

Anticipated

Interventions and Outcome Measures

Arms

Postoperative patients

Pediatric female patients undergoing a surgical procedure

Interventions

Pain

Postoperative pain levels

Opioid use

Postoperative opioid use

Primary outcome measure

  • Sex hormone level of Testosterone [ Time Frame: Baseline ]
  • Sex hormone level of estrogen [ Time Frame: Baseline ]
  • Sex hormone level of progesterone [ Time Frame: Baseline ]
  • Levels of IL-10 and IL-6 [ Time Frame: Baseline ]

Central Contacts and Locations

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Alana McMichael, MA

314-273-6194painlab@wustl.edu

Joel Brown

314-273-6194painlab@wustl.edu

Principal Investigator:

Hadas Nahman-Averbuch, PhD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-13.