Sex Hormones, Postoperative Pain and Opioid Use

Postoperative Pain Clinical Trial

— SPO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06023225
• Other study ID #: 202210083
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: July 1, 2027

Study information

• Verified date: September 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2025
• Gender: Female
• Age group: 11 Years to 16 Years

Eligibility

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).

Related Conditions & MeSH terms

• Opioid Use
• Pain, Postoperative
• Postoperative Pain

Intervention

Behavioral:
• Pain
Postoperative pain levels
• Opioid use
Postoperative opioid use

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sex hormone level of Testosterone		Baseline
Primary	Sex hormone level of estrogen		Baseline
Primary	Sex hormone level of progesterone		Baseline
Primary	Levels of IL-10 and IL-6	Immune factors	Baseline