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

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

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center

  lead OTHER

Principal Investigators

• Maurice M Garcia, M.D., MAS · Cedars-Sinai Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-11

Primary Completion

2026-09-30

Completion

2026-09-30

FDA Drug

Yes

Countries

• United States

Study Locations