Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
NCT ID: NCT04979338
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
640 participants
INTERVENTIONAL
2021-11-11
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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)
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 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
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)
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 \[administered by anesthesiologist post-op or at end of surgery\]
Local anesthetic
0.25% or 0.5% bupivacaine into the appropriate surgical site
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)
Bupivacaine
0.25% or 0.5% with or without 1:200K epinephrine
Bilateral spermatic cord block
10cc per spermatic cord of 0.5% bupivacaine \[administered by surgeon @ intraop\]
Local anesthetic
0.25% or 0.5% bupivacaine into the appropriate surgical site
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
18 Years
ALL
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Maurice M. Garcia
Director of the Cedars-Sinai Transgender Surgery and Health Program
Principal Investigators
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Maurice M Garcia, M.D., MAS
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Medical Center - North and South Towers
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00000879
Identifier Type: -
Identifier Source: org_study_id
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