Back to resultsDevelopment of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
Primary Purpose
Gender Dysphoria
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional treatment trial for Gender Dysphoria focused on measuring Gender Dysphoria, Gender-Affirming Surgery, Peri-Operative Pain, Pain Management, Surgery Pain, Sex Reassignment Surgery, Gender Reassignment Surgery, Vaginoplasty, Phalloplasty, Quality Improvement, Opioid Use
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
Sites / Locations
- Cedars-Sinai Medical Center - North and South TowersRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1
Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #2
Surgery-specific general anesthetic + local anesthetic at incision site
Arm Description
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)
Outcomes
Primary Outcome Measures
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."
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
Recorded number of post-operative days until commencement of regular passage of flatus will be obtained from hospital records.
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
Recorded number of post-operative days and experience of nausea will be obtained from hospital records.
Post-operative length of inpatient stay
Length of inpatient stay will be obtained from hospital records as the recorded number of days spent inpatient after surgery
Global satisfaction with respect to pain and physical comfort, as measured by a Quality of Recovery 15-Item Inventory
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).
Frequency of treatment complications
Treatment complications, such as hematoma, infection, etc., will only include those that are determined to be related to the study treatment.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04979338
Brief Title
Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
Official Title
Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gender Dysphoria
Keywords
Gender Dysphoria, Gender-Affirming Surgery, Peri-Operative Pain, Pain Management, Surgery Pain, Sex Reassignment Surgery, Gender Reassignment Surgery, Vaginoplasty, Phalloplasty, Quality Improvement, Opioid Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
640 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #2
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Surgery-specific general anesthetic + local anesthetic at incision site
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Ultrasound guided Continuous Infraclavicular Brachial Plexus Block
Intervention Description
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]
Intervention Type
Other
Intervention Name(s)
Ultrasound guided Continuous Femoral Nerve Block
Intervention Description
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]
Intervention Type
Other
Intervention Name(s)
Ultrasound guided Pudendal Nerve Block
Intervention Description
20-40cc of 0.25% bupivacaine + 1:200K epinephrine [administered by anesthesiologist, pre-incision]
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
0.25% or 0.5% with or without 1:200K epinephrine
Intervention Type
Other
Intervention Name(s)
Bilateral ultrasound guided Transversus Abdominis Plane Block
Intervention Description
40-60cc of 0.25% bupivacaine + 1:200K epinephrine [administered by anesthesiologist post-op or at end of surgery]
Intervention Type
Other
Intervention Name(s)
Bilateral spermatic cord block
Intervention Description
10cc per spermatic cord of 0.5% bupivacaine [administered by surgeon @ intraop]
Intervention Type
Other
Intervention Name(s)
Pecs I & II Block
Intervention Description
0.25% bupivacaine: 15-30mL per side for Pecs I-III
Intervention Type
Other
Intervention Name(s)
Local anesthetic
Intervention Description
0.25% or 0.5% bupivacaine into the appropriate surgical site
Primary Outcome Measure Information:
Title
Changes in peri-operative pain location and intensity over time, as measured by anatomic pain maps
Description
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)
Title
Changes in opioid consumption per 24 hours, measured by total inpatient and total outpatient
Description
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)
Title
Change in the opioid side effect of urinary retention, as indicated by time to spontaneous voiding
Description
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)
Title
Change in the opioid side effect of urinary retention, as measured by a Urinary Bother Symptom Score Questionnaire
Description
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)
Title
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
Description
Recorded number of post-operative days until commencement of regular passage of flatus will be obtained from hospital records.
Time Frame
Post-operative Day 1 to Discharge (average of 7 days after surgery)
Title
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
Description
Recorded number of post-operative days and experience of nausea will be obtained from hospital records.
Time Frame
Post-operative Day 1 to Discharge (average of 7 days after surgery)
Title
Post-operative length of inpatient stay
Description
Length of inpatient stay will be obtained from hospital records as the recorded number of days spent inpatient after surgery
Time Frame
Post-operative Day 1 to Discharge (average of 7 days after surgery)
Title
Global satisfaction with respect to pain and physical comfort, as measured by a Quality of Recovery 15-Item Inventory
Description
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).
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)
Title
Frequency of treatment complications
Description
Treatment complications, such as hematoma, infection, etc., will only include those that are determined to be related to the study treatment.
Time Frame
End of study (average of 30 days after surgery)
Secondary Outcome Measure Information:
Title
Time to mobilization
Description
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)
Title
Time to first day of bowel movement
Description
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)
Title
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)
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Transgender persons
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenna Stelmar, BS
Phone
805-813-7882
Email
jenna.stelmar@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurice M Garcia, M.D., MAS
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center - North and South Towers
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurice M Garcia, M.D., MAS
Phone
310-423-4256
Email
maurice.garcia@csmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
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