About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Ultrasound guided Continuous Infraclavicular Brachial Plexus Block
Other intervention20cc 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 intervention20cc 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 intervention20-40cc of 0.25% bupivacaine + 1:200K epinephrine \[administered by anesthesiologist, pre-incision\]
Bupivacaine
Drug0.25% or 0.5% with or without 1:200K epinephrine
Bilateral ultrasound guided Transversus Abdominis Plane Block
Other intervention40-60cc of 0.25% bupivacaine + 1:200K epinephrine \[administered by anesthesiologist post-op or at end of surgery\]
Bilateral spermatic cord block
Other intervention10cc per spermatic cord of 0.5% bupivacaine \[administered by surgeon @ intraop\]
Pecs I & II Block
Other intervention0.25% bupivacaine: 15-30mL per side for Pecs I-III
Local anesthetic
Other intervention0.25% or 0.5% bupivacaine into the appropriate surgical site
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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."
Secondary outcomes
Time to mobilization
The recorded number of days to mobilization will be obtained from hospital records.
Time to first day of bowel movement
The recorded number of days to first bowel movement will be obtained from hospital records.
Number of participants with any hospital readmission within 30 days of discharge
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