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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of this treatment for pain management in gender affirming surgery?

Research shows that ultrasound-guided pudendal nerve blocks can provide effective pain control in male patients undergoing urologic procedures, with most patients experiencing well-controlled pain postoperatively. Additionally, the transversus abdominis plane (TAP) block is effective for postoperative pain relief in abdominal surgeries, as it anesthetizes sensory nerves in the abdominal wall, providing safer and reliable analgesia. ^{1 2 3 4 5}

Is ultrasound-guided nerve block safe for pain management in surgeries?

Ultrasound-guided nerve blocks, such as the transversus abdominis plane (TAP) block and pudendal nerve block, have been shown to be safe and effective for pain management in various surgical procedures. Studies indicate that these techniques can provide good pain control with minimal complications when performed with ultrasound guidance. ^{1 2 3 6 7}

How does the treatment for opioid sparing pain management in gender affirming surgery differ from other treatments?

This treatment uses Pecs I and II nerve blocks, which are a type of regional anesthesia that targets specific nerves to reduce pain, potentially lowering the need for opioids. This approach is unique because it combines ultrasound guidance for precise delivery, making it safer and more effective in managing pain compared to traditional methods that rely heavily on opioids. ^{2 8 9 10 11}

Research Team

Maurice M Garcia, M.D., MAS

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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]

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]

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]

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 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]

References

1. Romania pubmed.ncbi.nlm.nih.gov

Pudendal nerve blocks in men undergoing urethroplasty: a case series. [2020]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Ultrasound-guided transversus abdominis plane injection with computed tomography correlation: a cadaveric study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided lateral and subcostal transversus abdominis plane block in calves: a cadaveric study. [2018]

4. Denmark pubmed.ncbi.nlm.nih.gov

Effective dermatomal blockade after subcostal transversus abdominis plane block. [2018]

5. Japan 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]. [2013]

6. Japan pubmed.ncbi.nlm.nih.gov

[Case of inguinal hernia repair with transversus abdominis plane block and rectus sheath block]. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Spread of injectate after ultrasound-guided subcostal transversus abdominis plane block: a cadaveric study. [2022]

8. France 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. [2022]

9. New Zealand 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. [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Combined ultrasound-guided Pecs II block and general anesthesia are effective for reducing pain from modified radical mastectomy. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

The Effect of Pectoral Nerve Blocks on Opioid use and Postoperative Pain in Masculinizing Mastectomy: A Randomized Controlled Trial. [2023]