Comparing pain management techniques for transgender patients undergoing gender-affirming surgeries
Official title: Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
Run by Cedars-Sinai Medical Center · NCT04979338 · Data updated 2026-11-12
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 | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 640 (estimated) |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Status | Recruiting |
| Started | November 11, 2021 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | September 17, 2025 |
| Trial ID | NCT04979338 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are transgender individuals aged 18 and older who are scheduled for gender-affirming surgeries.
✕Probably not a fit
Patients who do not meet the inclusion criteria or have contraindications to the study drugs may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promising results with similar pain management approaches, indicating potential for success in this area.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.