Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries
Cedars-Sinai Medical Center
640 participants
Nov 11, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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)
- 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
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Interventions
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 \[administered by anesthesiologist\]
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 \[administered by anesthesiologist\]
20-40cc of 0.25% bupivacaine + 1:200K epinephrine \[administered by anesthesiologist, pre-incision\]
0.25% or 0.5% with or without 1:200K epinephrine
40-60cc of 0.25% bupivacaine + 1:200K epinephrine \[administered by anesthesiologist post-op or at end of surgery\]
10cc per spermatic cord of 0.5% bupivacaine \[administered by surgeon @ intraop\]
0.25% bupivacaine: 15-30mL per side for Pecs I-III
0.25% or 0.5% bupivacaine into the appropriate surgical site
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04979338