Comparing pain management techniques for transgender patients undergoing gender-affirming surgeries
Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
PHASE3 · Cedars-Sinai Medical Center · NCT04979338
This study is testing different ways to manage pain for transgender patients having gender-affirming surgeries to see which method works best for them.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 640 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center (other) |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04979338 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of various pain management techniques for transgender individuals undergoing gender-affirming surgeries. It will compare standard-of-care options, including ultrasound-guided nerve blocks and local anesthetics, to determine which methods provide better pain relief post-surgery. The study will involve transgender patients aged 18 and older who are scheduled for specific surgical procedures performed by designated surgeons. By assessing pain outcomes, the research seeks to identify optimal strategies for managing peri-operative pain in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are transgender individuals aged 18 and older who are scheduled for gender-affirming surgeries.
Not a fit: Patients who do not meet the inclusion criteria or have contraindications to the study drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies that minimize opioid use for transgender patients undergoing surgery.
How similar studies have performed: Other studies have shown promising results with similar pain management approaches, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Transgender persons 18 years and older * Undergoing gender affirming surgeries performed by either Dr. Maurice Garcia (orchiectomy only, vaginoplasty with or without canal \& orchiectomy, colon-vaginoplasty, \& peritoneal vaginoplasty; Stage I phalloplasty, or stage II phalloplasty); Dr. Edward Ray (feminizing chest surgery, masculinizing chest surgery, stage I phalloplasty); Dr. Amit Gupta (orchiectomy and peritoneal vaginoplasty only); or Dr. Yosef Nasseri (colon vaginoplasty surgery) Exclusion Criteria: * Patients who do not meet the inclusion criteria above * Any contraindications to the study drugs. * Patients with neurologic deficits that preclude them from sensing pain. * Patients with implanted pain neuromodulator devices (e.g., neurostimulator) * Patients who do not speak English
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center - North and South Towers — Los Angeles, California, United States (RECRUITING)
Study contacts
- Principal investigator: Maurice M Garcia, M.D., MAS — Cedars-Sinai Medical Center
- Study coordinator: Jenna Stelmar, BS
- Email: jenna.stelmar@cshs.org
- Phone: 805-813-7882
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gender Dysphoria, Gender-Affirming Surgery, Peri-Operative Pain, Pain Management, Surgery Pain, Sex Reassignment Surgery, Gender Reassignment Surgery, Vaginoplasty