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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Ultrasound guided Continuous Infraclavicular Brachial Plexus Block
  • Ultrasound guided Continuous Femoral Nerve Block
  • Ultrasound guided Pudendal Nerve Block
  • Bupivacaine
  • Bilateral ultrasound guided Transversus Abdominis Plane Block
  • Bilateral spermatic cord block
  • Pecs I & II Block
  • Local anesthetic

Treatment groups

640 Participants
are divided into 3 treatment groups

Sponsors and collaborators