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NCT Number: NCT04979338

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

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.

Recruiting

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Key information

Conditions

Gender Dysphoria Agnosia Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Sexual Dysfunctions, Psychological Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cedars-Sinai Medical Center - North and South Towers

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Maurice M Garcia, M.D., MAS

CONTACT

[email protected]

310-423-4256

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound guided Continuous Infraclavicular Brachial Plexus Block

Other

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

Other

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

Other

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

Bupivacaine

Drug

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

Other names: Marcaine

Bilateral ultrasound guided Transversus Abdominis Plane Block

Other

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

Bilateral spermatic cord block

Other

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

Pecs I & II Block

Other

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

Local anesthetic

Other

0.25% or 0.5% bupivacaine into the appropriate surgical site

Primary outcomes

  1. 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)

    Anterior and posterior illustrations of the body, with pre-defined areas involved in surgery that may be circled, will be used to define pain location. Pain scores for each circled area will be measured on a Likert-scale between 0-10, with 0 indicating no pain and 10 indicating the worst pain experienced in respondent's life.

  2. 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)

    Inpatient opioid consumption will be obtained from hospital records. Outpatient opioid consumption will be determined from completed medication logs. Opioid consumption will be measured per 24 hours, by hospital location (e.g., PACU versus Ward), and by post-operative day.

  3. 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)

    Recorded time to spontaneous voiding will be collected from hospital records.

  4. 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)

    A Urinary Bother Symptom Score Questionnaire, obtained from the American Urological Association, will assess the frequency of different urinary problems, such as incomplete emptying, intermittency, and urgency. Each urinary problem will be measured on a scale from 0 to 5, with 0 indicating "none/not at all" and 5 indicating "almost always."

  5. 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)

    Recorded number of post-operative days until commencement of regular passage of flatus will be obtained from hospital records.

  6. 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)

    Recorded number of post-operative days and experience of nausea will be obtained from hospital records.

  7. Post-operative length of inpatient stay

    Time frame: Post-operative Day 1 to Discharge (average of 7 days after surgery)

    Length of inpatient stay will be obtained from hospital records as the recorded number of days spent inpatient after surgery

  8. 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)

    Questions 1-10 will assess global well-being and physical comfort, such as ability to return to work or usual home activities, feeling rested, ability to enjoy food, and general feelings of well-being. These questions will be rated on a scale of 0 to 10, with 0 indicating none of the time (poor) and 10 indicating all of the time (excellent).

    Questions 11-15 will assess pain and physical comfort, such as presence of moderate/severe pain, nausea or vomiting, worried or anxious feelings, and sad or depressed feelings. These questions will be rated on a scale of 0 to 10, with 0 indicating all of the time (poor) and 10 indicating none of the time (excellent).

  9. Frequency of treatment complications

    Time frame: End of study (average of 30 days after surgery)

    Treatment complications, such as hematoma, infection, etc., will only include those that are determined to be related to the study treatment.

Secondary outcomes

  1. Time to mobilization

    Time frame: Post-operative Day 1 to Discharge (average of 7 days after surgery)

    The recorded number of days to mobilization will be obtained from hospital records.

  2. Time to first day of bowel movement

    Time frame: Post-operative Day 1 to Discharge (average of 7 days after surgery)

    The recorded number of days to first bowel movement will be obtained from hospital records.

  3. Number of participants with any hospital readmission within 30 days of discharge

    Time frame: 30 days after Day of Discharge (average of 7 days after surgery)

Study contacts

Contact information is provided by the study sponsor or research team.

Jenna Stelmar, BS

CONTACT

[email protected]

805-813-7882

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2021
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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