Opioid Sparing Pain Management Techniques for Gender Affirming Surgery

Overseen By Jenna Stelmar, BS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Neurologic deficits, Implanted pain devices, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

640 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different pain management techniques for individuals undergoing gender-affirming surgery. The goal is to determine which method most effectively reduces post-surgery pain while minimizing opioid use. Participants will receive a combination of general anesthesia and either a local anesthetic, such as Bupivacaine, or an ultrasound-guided nerve block, a procedure that numbs specific nerves to reduce pain. Transgender individuals scheduled for specific gender-affirming surgeries may be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking pain management solution.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments in this trial are generally safe and well-tolerated. Here is a breakdown:

1. **Bilateral Spermatic Cord Block**: Studies indicate this procedure is safe and straightforward. It is often used in gender-affirming surgeries like orchiectomy, which many patients find effective and satisfying.

2. **Ultrasound Guided Transversus Abdominis Plane Block**: This technique reduces post-surgery pain and lessens the need for additional painkillers. Anesthesiologists are skilled in this method, and it is considered safe when performed with ultrasound to prevent complications.

3. **Bupivacaine (a local anesthetic)**: This drug is commonly used in surgeries to numb the area. While there are some risks, such as potential heart issues, it is generally safe when used properly.

4. **Pecs I & II Block**: This block significantly reduces the need for opioids and effectively controls pain after surgeries, especially mastectomies. It is considered safe and manages pain well.

5. **Ultrasound Guided Continuous Femoral Nerve Block**: Research shows this is effective for pain control. It may cause temporary leg muscle weakness, but this is usually mild.

6. **Ultrasound Guided Continuous Infraclavicular Brachial Plexus Block**: This block is effective for arm surgeries. It has a high success rate and usually does not require additional anesthesia.

7. **Ultrasound Guided Pudendal Nerve Block**: This block is a safe and effective way to manage pain during and after pelvic surgeries.

Overall, these treatments have been studied in various surgeries and are considered safe with manageable side effects. Always discuss any concerns with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these opioid-sparing pain management techniques for gender-affirming surgery because they aim to reduce reliance on opioids by using advanced nerve-blocking strategies. Unlike traditional pain management, which often heavily depends on opioid medications, these methods utilize a combination of ultrasound-guided nerve blocks and local anesthetics like bupivacaine. This approach targets specific nerves to provide pain relief directly at the surgical site or affected area, potentially reducing side effects and the risk of opioid dependence. By offering tailored pain management for different types of surgeries, these techniques might improve recovery times and overall patient comfort.

What evidence suggests that this trial's treatments could be effective for managing pain after gender-affirming surgery?

Research shows that the methods used in this trial may help manage pain after surgery. Participants may receive different combinations of treatments. For example, one arm includes ultrasound-guided nerve blocks, such as the Transversus Abdominis Plane (TAP) block, which has effectively reduced pain and the need for opioid painkillers post-surgery. Another arm may involve the PECS II block, which has also decreased opioid use and provided good pain relief, especially in gender-affirming surgeries. Bupivacaine, a local anesthetic used in various arms, is known for its long-lasting pain relief, reducing the need for stronger pain medications. Additionally, the ultrasound-guided pudendal nerve block, part of one trial arm, has improved pain control for certain surgeries, particularly those involving the urinary system. These treatments offer options that may lead to better pain management with fewer opioids needed. ^{6 7 8 9 10}

Who Is on the Research Team?

Maurice M Garcia, M.D., MAS

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for transgender individuals aged 18 or older who are undergoing gender-affirming surgeries with specific doctors. It's not for those with contraindications to study drugs, implanted pain devices, non-English speakers, or anyone unable to sense pain due to neurological deficits.

Exclusion Criteria

Patients with neurologic deficits that preclude them from sensing pain

Patients with implanted pain neuromodulator devices (e.g., neurostimulator)

I have no known allergies or reactions to the study drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo gender-affirming surgery with various anesthetic techniques to manage peri-operative pain

1 day

1 visit (in-person)

Post-operative Care

Participants are monitored for pain management and opioid side effects, with inpatient stay averaging 7 days

7 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and satisfaction with pain management after discharge

30 days

Final post-operative visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bilateral spermatic cord block
• Bilateral ultrasound guided Transversus Abdominis Plane Block
• Bupivacaine
• Local anesthetic
• Pecs I & II Block
• Ultrasound guided Continuous Femoral Nerve Block
• Ultrasound guided Continuous Infraclavicular Brachial Plexus Block
• Ultrasound guided Pudendal Nerve Block

Trial Overview The study compares different opioid-sparing pain management techniques after gender-affirming surgery. Techniques include various nerve blocks and local anesthetics like Bupivacaine, aiming to find the most effective method for reducing post-operative pain.

How Is the Trial Designed?

Group I: Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1 Active Control 7 Interventions

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)

Group II: Surgery-specific general anesthetic + local anesthetic at incision site Active Control 3 Interventions

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)

Group III: Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #2 Active Control 3 Interventions

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)

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Published Research Related to This Trial

The study involved 20 awake patients undergoing elective abdominal surgery, where a subcostal TAP block was performed using 20 ml of 0.5% ropivacaine, resulting in sensory changes in dermatomes T10-T12 for all patients after 30 minutes.

Sensory assessment using cold and pinprick sensation effectively determined the extent of sensory blockade, confirming the TAP block's efficacy in managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective dermatomal blockade after subcostal transversus abdominis plane block. Mitchell, AU., Torup, H., Hansen, EG., et al.[2018]

The ultrasound-guided subcostal transversus abdominis plane (TAP) block effectively targets nerve roots T9 and T10 with a single injection, and T9, T10, and T11 with multiple injections, indicating its potential for effective pain management in abdominal procedures.

Using a multiple-injection technique significantly increases the spread of the anesthetic, with a median spread of 90 cm² compared to 60 cm² with a single injection, suggesting that this method may enhance the efficacy of the block.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spread of injectate after ultrasound-guided subcostal transversus abdominis plane block: a cadaveric study. Barrington, MJ., Ivanusic, JJ., Rozen, WM., et al.[2022]

The study involving 50 patients undergoing modified radical mastectomy demonstrated that the ultrasound-guided Pecs II block significantly reduced intraoperative opioid consumption and postoperative pain compared to the control group.

There were no complications associated with the Pecs II block, indicating it is a safe and effective method for pain management in breast surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined ultrasound-guided Pecs II block and general anesthesia are effective for reducing pain from modified radical mastectomy. Senapathi, TGA., Widnyana, IMG., Aribawa, IGNM., et al.[2020]

In a study of 50 patients undergoing bilateral masculinizing mastectomy, the use of pectoral nerve blocks did not significantly reduce intraoperative or postoperative opioid consumption compared to a placebo, indicating limited efficacy of this pain management technique.

Postoperative pain scores were similar between the Pecs block group and the control group, suggesting that a postoperative opioid-sparing approach may be suitable for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Pectoral Nerve Blocks on Opioid use and Postoperative Pain in Masculinizing Mastectomy: A Randomized Controlled Trial. Wallace, AB., Song, S., Yeh, P., et al.[2023]

Ultrasound-guided transversus abdominis plane (TAP) injections allow for more accurate placement of anesthetic, and this study found that increasing the volume of injected contrast (5, 10, 15, or 20 mL) correlates with greater spread in the abdominal wall, with 15 mL providing optimal coverage.

The study, conducted on 2 fresh frozen cadaver torsos, showed that 5 mL resulted in about 1 vertebral level of spread, while 10, 15, and 20 mL resulted in approximately 2 vertebral levels, indicating that larger volumes may enhance the effectiveness of the block, although results may vary in live patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided transversus abdominis plane injection with computed tomography correlation: a cadaveric study. Moeschler, SM., Murthy, NS., Hoelzer, BC., et al.[2022]

In a study involving 76 patients undergoing elective cesarean sections, the ultrasound-guided posterior TAP block was found to be more effective in controlling pain compared to the lateral TAP block, particularly at 6, 12, and 24 hours post-surgery.

Patients who received the posterior TAP block reported significantly lower pain levels at rest compared to those who received the lateral TAP block, indicating that the posterior approach may provide better pain management after abdominal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of ultrasound-guided posterior transversus abdominis plane block and lateral transversus abdominis plane block for postoperative pain management in patients undergoing cesarean section: a randomized double-blind clinical trial study. Faiz, SHR., Alebouyeh, MR., Derakhshan, P., et al.[2022]

The ultrasound-guided transversus abdominis plane (TAP) block was found to be feasible and easy to perform in calf cadavers, with excellent scores for both objective and subjective assessments of the technique.

Both 0.2 mL/kg and 0.4 mL/kg volumes of injectate showed similar effectiveness in staining nerves, indicating that the volume does not significantly affect the spread of the solution, and further studies are needed to optimize the technique for pain management in calves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided lateral and subcostal transversus abdominis plane block in calves: a cadaveric study. Mirra, A., von Rotz, A., Schmidhalter, M., et al.[2018]

The transversus abdominis plane (TAP) block, performed using ultrasound guidance, provides a safer and more reliable method for pain management in patients undergoing surgery, as demonstrated in a case involving a patient with severe cardiac dysfunction and chronic kidney failure.

In this case, the TAP block was successfully administered bilaterally with ropivacaine, leading to an uneventful perioperative course without any adverse effects, including central nervous system symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bilateral transversus abdominis plane block using catheterization for a patient with severe cardiac dysfunction and chronic kidney failure: a case report]. Doi, H., Arai, F., Kobayashi, S.[2013]

The pudendal nerve block (PNB) can be effectively performed in male patients undergoing urethroplasty, providing safe pain control with the aid of ultrasound guidance to identify anatomical landmarks.

In a small study of three male patients, two experienced well-controlled pain 24 hours post-surgery, while one required additional pain relief, indicating that PNB can be a beneficial analgesic technique in urologic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pudendal nerve blocks in men undergoing urethroplasty: a case series. Kalava, A., Pribish, AM., Wiegand, LR.[2020]

In a study involving 41 infants and children undergoing elective inguinal surgery, the ilioinguinal block provided more effective pain relief compared to the TAP block, as indicated by lower pain frequency and reduced ibuprofen use in the ilioinguinal group.

Although the TAP block had longer needle time and poorer ultrasound image quality, it did not significantly differ in recovery room pain, morphine consumption, or parental satisfaction compared to the ilioinguinal block.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved analgesia with the ilioinguinal block compared to the transversus abdominis plane block after pediatric inguinal surgery: a prospective randomized trial. Fredrickson, MJ., Paine, C., Hamill, J.[2022]

Ultrasound-guided nerve blocks, specifically the transversus abdominis plane block and rectus sheath block, are effective alternatives to general anesthesia for lower abdominal and inguinal surgeries.

In an 82-year-old patient with severe health issues, these blocks provided effective anesthetic management, highlighting their safety and efficacy in high-risk surgical patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Case of inguinal hernia repair with transversus abdominis plane block and rectus sheath block]. Tanaka, M., Azuma, S., Hasegawa, Y., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04979338

Study Details | NCT04979338 | Development of Effective, ... Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries.

2. withpower.com withpower.com/trial/phase-3-gender-dysphoria-7-2021-d11d5

Opioid Sparing Pain Management Techniques for Gender ... This study will compare the current standard-of-care pain treatment regimen options that are available to patients who undergo gender-affirming surgery.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39027810/

Battle of the Blocks: Which Pain Management Technique ... The PECS 2 block is superior in reducing overall opioid consumption and providing effective postoperative pain control in gender-affirming mastectomies.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11254309/

Battle of the Blocks: Which Pain Management Technique ... The PECS 2 block is superior in reducing overall opioid consumption and providing effective postoperative pain control in gender-affirming mastectomies.

5. bjanaesthesia.org.uk bjanaesthesia.org.uk/article/S0007-0912(17)33332-9/fulltext

Ultrasound-guided spermatic cord block for scrotal surgery Performing spermatic cord block for scrotal surgery avoids the potential risks of neuraxial and general anaesthesia and provides long-lasting postoperative ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12016241/

Gender-affirming orchiectomy in transgender and non ... Gender-affirming orchiectomy is a simple and safe procedure. It can be performed as standalone gender-affirming surgical procedure, or as bridge to another ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12374367/

Orchiectomy and scrotectomy as genital gender-affirming ... Bilateral orchiectomy proceeds by skeletonizing each spermatic cord to the level of the external inguinal ring, excising it after clamping ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2050052119301209

A Simple Guide for Simple Orchiectomy in Transition- ... We describe the indications, surgical approach, preoperative and postoperative assessment, and the risks and benefits of bilateral simple orchiectomy in the ...

9. academic.oup.com academic.oup.com/smoa/article/12/4/qfae048/7744907

Endocrine, gender dysphoria, and sexual function benefits of ... A majority of patients who underwent standalone gender-affirming bilateral orchiectomy (sGABO) reported satisfaction across five different ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S152169342200178X

12 Genital gender-affirming surgery for transgender women Bilateral orchiectomy, as is performed in all gGAS procedures, causes infertility, and individuals need to be counseled preoperatively on reproductive functions ...