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

NCT04979338 | Recruiting Phase 3 FDA Drug

• 1 other identifier: STUDY00000879
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (9)

• Changes in peri-operative pain location and intensity over time, as measured by anatomic pain maps

  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.

  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

  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.

  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

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

  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

  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."

  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

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

  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

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

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

• Post-operative length of inpatient stay

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

  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

  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).

  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

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

  End of study (average of 30 days after surgery)

Secondary Outcomes (3)

• Time to mobilization

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

• Time to first day of bowel movement

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

• Number of participants with any hospital readmission within 30 days of discharge

  30 days after Day of Discharge (average of 7 days after surgery)

Study Arms (3)

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

ACTIVE COMPARATOR

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)

Other: Ultrasound guided Continuous Infraclavicular Brachial Plexus Block; Other: Ultrasound guided Continuous Femoral Nerve Block; Other: Ultrasound guided Pudendal Nerve Block; Drug: Bupivacaine; Other: Bilateral spermatic cord block; Other: Pecs I & II Block; Other: Local anesthetic

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

ACTIVE COMPARATOR

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)

Drug: Bupivacaine; Other: Bilateral ultrasound guided Transversus Abdominis Plane Block; Other: Local anesthetic

Surgery-specific general anesthetic + local anesthetic at incision site

ACTIVE COMPARATOR

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)

Drug: Bupivacaine; Other: Bilateral spermatic cord block; Other: Local anesthetic

Interventions

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 \[administered by anesthesiologist\]

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

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 \[administered by anesthesiologist\]

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

Ultrasound guided Pudendal Nerve Block OTHER

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

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

Bupivacaine DRUG

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

Also known as: Marcaine

Surgery-specific general anesthetic + local anesthetic at incision site; Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1; Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #2

Bilateral ultrasound guided Transversus Abdominis Plane Block OTHER

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

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

Bilateral spermatic cord block OTHER

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

Surgery-specific general anesthetic + local anesthetic at incision site; Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1

Pecs I & II Block OTHER

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

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

Local anesthetic OTHER

0.25% or 0.5% bupivacaine into the appropriate surgical site

Surgery-specific general anesthetic + local anesthetic at incision site; Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1; Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #2

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Transgender persons
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center - North and South Towers

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Gender Dysphoria; Agnosia

Interventions

Bupivacaine; Dental Occlusion; Anesthetics, Local

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Maurice M Garcia, M.D., MAS

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenna Stelmar, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Cedars-Sinai Transgender Surgery and Health Program

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 28, 2021
• Study Start: November 11, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)