Recruiting
Phase 3

Pain Management

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT04979338

Conditions

Gender Dysphoria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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

Study ID

NCT04979338

Start date

Nov 11, 2021

Status verified date

Sep, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

640 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1

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)

active comparator: Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #2

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)

active comparator: Surgery-specific general anesthetic + local anesthetic at incision site

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)

Interventions

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 \[administered by anesthesiologist\]

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 \[administered by anesthesiologist\]

Ultrasound guided Pudendal Nerve Block

20-40cc of 0.25% bupivacaine + 1:200K epinephrine \[administered by anesthesiologist, pre-incision\]

Bupivacaine

0.25% or 0.5% with or without 1:200K epinephrine

Bilateral ultrasound guided Transversus Abdominis Plane Block

40-60cc of 0.25% bupivacaine + 1:200K epinephrine \[administered by anesthesiologist post-op or at end of surgery\]

Bilateral spermatic cord block

10cc per spermatic cord of 0.5% bupivacaine \[administered by surgeon @ intraop\]

Pecs I & II Block

0.25% bupivacaine: 15-30mL per side for Pecs I-III

Local anesthetic

0.25% or 0.5% bupivacaine into the appropriate surgical site

Primary outcome measure

  • Changes in peri-operative pain location and intensity over time, as measured by anatomic pain maps [ Time Frame: Any time pain is experienced, starting on the morning of post-operative Day 1 to End of Study at the final post-operative visit (average of 30 days after surgery) ]
  • Changes in opioid consumption per 24 hours, measured by total inpatient and total outpatient [ Time Frame: Per 24 hours, starting on post-operative Day 1 to End of Study at the final post-operative visit (average of 30 days after surgery) ]
  • Change in the opioid side effect of urinary retention, as indicated by time to spontaneous voiding [ Time Frame: Post-operative Day 1 to Discharge (average of 7 days after surgery) ]
  • Change in the opioid side effect of urinary retention, as measured by a Urinary Bother Symptom Score Questionnaire [ Time Frame: Pre-operative visit, Discharge (average of 7 days after surgery), and End of Study/final post-operative visit (average of 30 days after surgery) ]
  • Change in the opioid side effect of decreased GI motility and ileus, as indicated by number of post-operative days until commencement of regular passage of flatus [ Time Frame: Post-operative Day 1 to Discharge (average of 7 days after surgery) ]
  • Change in the opioid side effect of nausea, as indicated by number of post-operative days to toleration of liquid diet and regular diet, as well as reported experience of nausea [ Time Frame: Post-operative Day 1 to Discharge (average of 7 days after surgery) ]
  • Post-operative length of inpatient stay [ Time Frame: Post-operative Day 1 to Discharge (average of 7 days after surgery) ]
  • Global satisfaction with respect to pain and physical comfort, as measured by a Quality of Recovery 15-Item Inventory [ Time Frame: Daily, starting on the morning of post-operative Day 1 to End of Study at the final post-operative visit (average of 30 days after surgery) ]
  • Frequency of treatment complications [ Time Frame: End of study (average of 30 days after surgery) ]

Central Contacts and Locations

Central contacts

Jenna Stelmar, BS

805-813-7882jenna.stelmar@cshs.org

Locations

Cedars-Sinai Medical Center - North and South Towers

Recruiting

Los Angeles, California, United States, 90048

Contacts

Maurice M Garcia, M.D., MAS

310-423-4256maurice.garcia@csmc.edu

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Sep 17, 2025

Last verified

Sep, 2025

Keywords

  • Gender Dysphoria
  • Gender-Affirming Surgery
  • Peri-Operative Pain
  • Pain Management
  • Surgery Pain
  • Sex Reassignment Surgery
  • Gender Reassignment Surgery
  • Vaginoplasty
  • Phalloplasty
  • Quality Improvement
  • Opioid Use

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2025-09-17.