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

Overview

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.

Interventions

• Other 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 \[administered by anesthesiologist\]
• Other 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 \[administered by anesthesiologist\]
• Other Ultrasound guided Pudendal Nerve Block
  20-40cc of 0.25% bupivacaine + 1:200K epinephrine \[administered by anesthesiologist, pre-incision\]
• Drug Bupivacaine
  0.25% or 0.5% with or without 1:200K epinephrine
• Other Bilateral ultrasound guided Transversus Abdominis Plane Block
  40-60cc of 0.25% bupivacaine + 1:200K epinephrine \[administered by anesthesiologist post-op or at end of surgery\]
• Other Bilateral spermatic cord block
  10cc per spermatic cord of 0.5% bupivacaine \[administered by surgeon @ intraop\]
• Other Pecs I & II Block
  0.25% bupivacaine: 15-30mL per side for Pecs I-III
• Other Local anesthetic
  0.25% or 0.5% bupivacaine into the appropriate surgical site

Primary outcome measures

• 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)]
• Changes in opioid consumption per 24 hours, measured by total inpatient and total outpatient [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)]
• Change in the opioid side effect of urinary retention, as indicated by time to spontaneous voiding [Time frame: 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 [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)]
• 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 [Time frame: 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 [Time frame: Post-operative Day 1 to Discharge (average of 7 days after surgery)]
• Post-operative length of inpatient stay [Time frame: 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 [Time frame: 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 [Time frame: End of study (average of 30 days after surgery)]

Secondary outcome measures (3)

• Time to mobilization [Time frame: Post-operative Day 1 to Discharge (average of 7 days after surgery)]
• Time to first day of bowel movement [Time frame: Post-operative Day 1 to Discharge (average of 7 days after surgery)]
• 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)]

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• 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)
• Patients who do not speak English

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Cedars-Sinai Medical Center - North and South Towers — Los Angeles

Identifiers

NCT: NCT04979338 · STUDY00000879

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗