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.

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

Gender Dysphoria

Ultrasound guided Continuous Infraclavicular Brachial Plexus Block

Ultrasound guided Continuous Femoral Nerve Block

Ultrasound guided Pudendal Nerve Block

Bupivacaine

Bilateral ultrasound guided Transversus Abdominis Plane Block

Bilateral spermatic cord block

Pecs I & II Block

Local anesthetic

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.

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.

Recorded time to spontaneous voiding will be collected from hospital records.

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."

Recorded number of post-operative days until commencement of regular passage of flatus will be obtained from hospital records.

Recorded number of post-operative days and experience of nausea will be obtained from hospital records.

Length of inpatient stay will be obtained from hospital records as the recorded number of days spent inpatient after surgery

Questions 1-10 will assess global well-being and physical comfort, such as ability to return to work or usual home activities, feeling rested, ability to enjoy food, and general feelings of well-being. These questions will be rated on a scale of 0 to 10, with 0 indicating none of the time (poor) and 10 indicating all of the time (excellent).
Questions 11-15 will assess pain and physical comfort, such as presence of moderate/severe pain, nausea or vomiting, worried or anxious feelings, and sad or depressed feelings. These questions will be rated on a scale of 0 to 10, with 0 indicating all of the time (poor) and 10 indicating none of the time (excellent).

Treatment complications, such as hematoma, infection, etc., will only include those that are determined to be related to the study treatment.

Director of the Cedars-Sinai Transgender Surgery and Health Program

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

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

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)

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)

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)

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status