NCT04979338

Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 640 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gender Dysphoria

Interventions

Type	Name	Description
OTHER	Ultrasound guided Continuous Infraclavicular Brachial Plexus Block	20cc of 0.25% bupivacaine + 1:200K epinephrine will be administered at start of case, 20cc of 0.25% bupivacaine + 1:200K epinephrine at end of case, and 6cc/hr of 0.25% bupivacaine at post-op \[administered by anesthesiologist\]
OTHER	Ultrasound guided Continuous Femoral Nerve Block	20cc of 0.25% bupivacaine + 1:200K epinephrine will be administered at start of case, 20cc of 0.25% bupivacaine + 1:200K epinephrine at end of case, and 6cc/hr of 0.25% bupivacaine at post-op \[administered by anesthesiologist\]
OTHER	Ultrasound guided Pudendal Nerve Block	20-40cc of 0.25% bupivacaine + 1:200K epinephrine \[administered by anesthesiologist, pre-incision\]
DRUG	Bupivacaine	0.25% or 0.5% with or without 1:200K epinephrine
OTHER	Bilateral ultrasound guided Transversus Abdominis Plane Block	40-60cc of 0.25% bupivacaine + 1:200K epinephrine \[administered by anesthesiologist post-op or at end of surgery\]
OTHER	Bilateral spermatic cord block	10cc per spermatic cord of 0.5% bupivacaine \[administered by surgeon @ intraop\]
OTHER	Pecs I & II Block	0.25% bupivacaine: 15-30mL per side for Pecs I-III
OTHER	Local anesthetic	0.25% or 0.5% bupivacaine into the appropriate surgical site

Timeline

• Start date: 2021-11-11
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2021-07-28
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study