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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT04979338
Phase
PHASE3
Status
Recruiting
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Conditions

  • Gender Dysphoria

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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 \[administered by anesthesiologist\]
  • 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
  • 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

Study Details

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.

Key Dates

Start date
Nov 11, 2021
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
640 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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)

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical Center - North and South TowersLos AngelesCalifornia90048
Maurice M Garcia, M.D., MAS
[email protected]
310-423-4256

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Cedars-Sinai Medical Center - North and South Towers· Los Angeles, CA

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