Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
Status and phase
Enrolling
Phase 3
Conditions
Gender Dysphoria
Treatments
Other: Bilateral spermatic cord block
Other: Pecs I & II Block
Other: Ultrasound guided Continuous Femoral Nerve Block
Other: Ultrasound guided Continuous Infraclavicular Brachial Plexus Block
Other: Bilateral ultrasound guided Transversus Abdominis Plane Block
Other: Ultrasound guided Pudendal Nerve Block
Drug: Bupivacaine
Other: Local anesthetic
Details and patient eligibility
About
This study will compare the current standard-of-care pain treatment regimen options that are available to patients who undergo gender-affirming surgery. The purpose of this research is to determine if any of these options are more (versus less) effective than the others to manage surgery related pain, after surgery.
Enrollment
640 estimated patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
640 participants in 3 patient groups
Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1
Active Comparator group
Description:
Depending on which one of the thirteen possible gender-affirming surgeries the participant is undergoing, a combination of the following anesthetic block(s) will be used in this arm at either the pre-incision, intra-op, mid-surgery, end of surgery, or continuous time points:
* Bilateral spermatic cord block (0.5% bupivacaine, 10cc per spermatic cord)
* Local anesthetic (0.25% or 0.5% bupivacaine + 1:200K epinephrine)
* Bilateral ultrasound guided pudendal nerve block (20-40 cc of 0.25% bupivacaine + 1:200K epinephrine)
* Ultrasound guided Continuous Infraclavicular Brachial Plexus Block
* Ultrasound guided Continuous Femoral Nerve Block
* Pecs I \& II Block (0.25% bupivacaine: 15-30ml per side for Pecs I-III)
Treatment:
Other: Local anesthetic
Drug: Bupivacaine
Other: Ultrasound guided Pudendal Nerve Block
Other: Ultrasound guided Continuous Infraclavicular Brachial Plexus Block
Other: Pecs I & II Block
Other: Ultrasound guided Continuous Femoral Nerve Block
Other: Bilateral spermatic cord block
Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #2
Active Comparator group
Description:
Depending on which one of the thirteen possible gender-affirming surgeries the participant is undergoing, a combination of the following anesthetic block(s) will be used in this arm at either the intra-op, post-op, or end of surgery time points:
* Bilateral ultrasound-guided Transversus Abdominis Plane Block (40-60cc of 0.25% bupivacaine with 1:200K epinephrine)
* Local anesthetic (0.25 or 0.5% bupivacaine + 1:200K epinephrine)
Treatment:
Other: Local anesthetic
Drug: Bupivacaine
Other: Bilateral ultrasound guided Transversus Abdominis Plane Block
Surgery-specific general anesthetic + local anesthetic at incision site
Active Comparator group
Description:
Depending on which one of the thirteen possible gender-affirming surgeries the participant is undergoing, a combination of the following anesthetic block(s) will be used in this arm at either the mid-surgery or end of surgery time points:
* Bilateral spermatic cord block (0.5% bupivacaine, 10cc per spermatic cord)
* Local anesthetic (0.25 or 0.5% bupivacaine + 1:200K epinephrine)
Treatment:
Other: Local anesthetic
Drug: Bupivacaine
Other: Bilateral spermatic cord block
Trial contacts and locations
1
Loading...
Central trial contact
Jenna Stelmar, BS
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems