NCT06023225

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
38mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Sep 2023Jul 2029

First Submitted

Initial submission to the registry

August 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

3.8 years

First QC Date

August 28, 2023

Last Update Submit

August 12, 2025

Conditions

Postoperative PainOpioid Use

Outcome Measures

Primary Outcomes (4)

  • Sex hormone level of Testosterone

    Baseline

  • Sex hormone level of estrogen

    Baseline

  • Sex hormone level of progesterone

    Baseline

  • Levels of IL-10 and IL-6

    Immune factors

    Baseline

Study Arms (1)

Postoperative patients

Pediatric female patients undergoing a surgical procedure

Behavioral: PainBehavioral: Opioid use

Interventions

PainBEHAVIORAL

Postoperative pain levels

Postoperative patients
Opioid useBEHAVIORAL

Postoperative opioid use

Postoperative patients

Eligibility Criteria

Age11 Years - 16 Years
Sexfemale
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Pediatric female patients between the ages 11-16 undergoing an orthopedic surgical procedure

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy; Diagnosis of chronic pain, Psychiatric, developmental or neurological disorders, Disorders that are associated with pubertal maturation (e.g., precocious puberty).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst Prof of Anesthesiology

Study Record Dates

First Submitted

August 28, 2023

First Posted

September 5, 2023

Study Start

September 1, 2023

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2029

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)