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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Ultrasound guided Continuous Infraclavicular Brachial Plexus Block

    Other intervention

    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 intervention

    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 intervention

    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 intervention

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

  • Bilateral spermatic cord block

    Other intervention

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

  • Pecs I & II Block

    Other intervention

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

  • Local anesthetic

    Other intervention

    0.25% or 0.5% bupivacaine into the appropriate surgical site

Treatment groups

640 Participants
are divided into 3 treatment groups
Group A: Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1Active comparator 7 interventions
Group B: Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #2Active comparator 3 interventions
Group C: Surgery-specific general anesthetic + local anesthetic at incision siteActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.

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)
2

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.

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)
3

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.

Time frame
Post-operative Day 1 to Discharge (average of 7 days after surgery)
4

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."

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)

Secondary outcomes

1

Time to mobilization

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

Time frame
Post-operative Day 1 to Discharge (average of 7 days after surgery)
2

Time to first day of bowel movement

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

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

Other outcomes

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