Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1 for Gender Dysphoria

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Gender Dysphoria+1 MoreUltrasound guided Continuous Infraclavicular Brachial Plexus Block - Other
Eligibility
18+
All Sexes
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Study Summary

This trial will compare different pain treatment options for people undergoing gender-affirming surgery, to see which are more effective in managing post-surgical pain.

Eligible Conditions
  • Gender Dysphoria

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

9 Primary · 3 Secondary · Reporting Duration: 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)

Day 30
Number of participants with any hospital readmission within 30 days of discharge
Day 30
Changes in peri-operative pain location and intensity over time, as measured by anatomic pain maps
Day 30
Pain
Day 30
Frequency of treatment complications
Day 30
Changes in opioid consumption per 24 hours, measured by total inpatient and total outpatient
Day 7
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
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
Change in the opioid side effect of urinary retention, as indicated by time to spontaneous voiding
Post-operative length of inpatient stay
Time to first day of bowel movement
Time to mobilization
Day 30
Change in the opioid side effect of urinary retention, as measured by a Urinary Bother Symptom Score Questionnaire

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #...
1 of 3
Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #...
1 of 3
Surgery-specific general anesthetic + local anesthetic at incision site
1 of 3

Active Control

640 Total Participants · 3 Treatment Groups

Primary Treatment: Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1 · No Placebo Group · Phase 3

Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1ActiveComparator Group · 7 Interventions: Ultrasound guided Continuous Infraclavicular Brachial Plexus Block, Local anesthetic, Ultrasound guided Continuous Femoral Nerve Block, Ultrasound guided Pudendal Nerve Block, Pecs I & II Block, Bupivacaine, Bilateral spermatic cord block · Intervention Types: Other, Other, Other, Other, Other, Drug, Other
Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #2ActiveComparator Group · 3 Interventions: Bilateral ultrasound guided Transversus Abdominis Plane Block, Local anesthetic, Bupivacaine · Intervention Types: Other, Other, Drug
Surgery-specific general anesthetic + local anesthetic at incision siteActiveComparator Group · 3 Interventions: Local anesthetic, Bupivacaine, Bilateral spermatic cord block · Intervention Types: Other, Drug, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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)

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
457 Previous Clinical Trials
153,765 Total Patients Enrolled
Maurice M Garcia, M.D., MASPrincipal InvestigatorCedars-Sinai Medical Center

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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