Saddle Block With IT Morphine for Postoperative Pain

Overseen By Didem Bozak

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Women's College Hospital

Must not be taking: Oxycodone

Disqualifiers: Local infection, Revision surgeries, others

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate pre-operative period

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage pain after penile inversion vaginoplasty, a specific gender-affirming surgery. Researchers aim to determine if adding a saddle block with intrathecal (spinal) morphine can reduce severe post-surgery pain. Participants will receive either this new pain management method or a standard care plan. The trial seeks individuals who have undergone or plan to undergo penile inversion vaginoplasty and have not been using high doses of pain medication regularly. As an unphased trial, it offers participants the chance to contribute to innovative pain management strategies for gender-affirming surgeries.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are using over 30mg of oxycodone or its equivalent per day, you would not be eligible to participate.

What prior data suggests that the saddle block with intrathecal morphine is safe for postoperative pain management?

Studies have shown that intrathecal morphine effectively relieves pain, particularly for surgeries on the lower body, such as knee or hip replacements. Notably, this pain control method does not increase the risk of breathing problems, a common concern with opioid use. Research indicates that a dose of up to 100 micrograms of morphine is generally safe for patients.

Although no studies directly relate to the exact procedure in this trial, available data suggests that intrathecal morphine is well-tolerated, meaning patients usually experience no serious side effects. For those considering joining a trial involving this pain management method, this evidence may provide reassurance about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatment using a saddle block with intrathecal morphine for postoperative pain because it offers a unique approach to pain management. Unlike standard treatments that typically involve general systemic analgesics like acetaminophen, NSAIDs, and opioids, this method targets pain directly at the spinal level through the intrathecal space, potentially providing more effective and localized pain relief. Additionally, the use of intrathecal morphine, a potent pain reliever, may reduce the need for higher doses of systemic opioids, minimizing their side effects. This innovative delivery method could enhance recovery and improve comfort for patients after surgery.

What evidence suggests that the saddle block with intrathecal morphine could be effective for postoperative pain in penile inversion vaginoplasty?

Research has shown that using a saddle block with spinal morphine can help manage post-surgical pain. In this trial, participants in the "Saddle block with intrathecal morphine Group" will receive an injection of bupivacaine combined with spinal morphine. Studies have found this combination reduces pain both during and after the procedure. This type of pain relief can also decrease the overall need for pain medications. Previous studies suggest that combining bupivacaine, a numbing medicine, with spinal morphine provides better pain control, indicating its effectiveness for managing pain after penile inversion vaginoplasty. ^{1 6 7 8 9}

Who Is on the Research Team?

Laura Giron-Arango, MD

Principal Investigator

Women's College Hospital

Richard Brull, MD

Principal Investigator

Women's College Hospital

Are You a Good Fit for This Trial?

This trial is for individuals aged 15-70 undergoing Penile Inversion Vaginoplasty, a gender-affirming surgery. Participants should be relatively healthy (ASA I-III), which means they can have mild to severe systemic disease but are not at risk of life-threatening conditions.

Inclusion Criteria

My health is good to moderately impaired.

I am between 15 and 70 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a saddle block with intrathecal morphine or a sham saddle block in addition to standard multimodal analgesic regimen

Immediate pre-operative period

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for block-related complications, opioid consumption, pain assessment, and patient satisfaction

48 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Saddle Block With IT Morphine

Trial Overview The study is testing the effectiveness of two pain management techniques after gender-affirming surgery: pudendal nerve block and saddle block with intrathecal morphine. The goal is to see if these methods reduce severe postoperative pain more effectively than current strategies.

How Is the Trial Designed?

Group I: Saddle block with intrathecal morphine Group Experimental Treatment 2 Interventions

Patients will receive a multimodal analgesic regimen with acetaminophen, NSAIDs and opioids plus a surgeon-administered pudendal nerve block by anatomical landmarks with 50mL of Normal Saline, 30mL of 0.25% Bupivacaine with epinephrine 1:200.000 and 20mL Lidocaine 1%. A volume of 20 mL of this mixture is used for the pudendal nerve block, and infiltration of the surgical incision and bilateral spermatic cord block is performed with an additional 20 mL of the same mixture of local anesthetic. 30ml of the solution is used to soak the vaginal plug made of gauze that is put inside the vaginal canal by the end of the procedure. Patients who are randomized to the saddle block with intrathecal morphine will receive an injection of 5mg of heavy Bupivacaine 0.75% plus 100mcg of morphine injected in the intrathecal space.

Group II: Control Group Placebo Group 1 Intervention

As part of the analgesic plan, all patients will receive a multimodal analgesic regimen with acetaminophen, NSAIDs and opioids plus a surgeon-administered pudendal nerve block by anatomical landmarks with 50mL of Normal Saline, 30mL of 0.25% Bupivacaine with epinephrine 1:200.000 and 20mL Lidocaine 1%. A volume of 20 mL of this mixture is used for the pudendal nerve block, and infiltration of the surgical incision and bilateral spermatic cord block is performed with an additional 20 mL of the same mixture of local anesthetic. 30ml of the solution is used to soak the vaginal plug made of gauze that is put inside the vaginal canal by the end of the procedure. Patients in this group will receive a non-invasive sham saddle block in addition to the care standard.

Who Is Running the Clinical Trial?

Women's College Hospital

Lead Sponsor

Trials

108

Recruited

43,700+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1365182X21001787

Evaluation of the addition of bupivacaine to intrathecal ... The aim of this retrospective study was to compare the analgesic efficacy and other secondary benefits of the addition of hyperbaric bupivacaine to intrathecal ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK67717/

Intraoperative and postoperative analgesic efficacy ... - NCBI To investigate the effect of intrathecal opioids added to spinal anaesthesia on intra-operative and post-operative pain, and to evaluate adverse effects.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06556121

Saddle Block With IT Morphine for Penile Inversion ... We hypothesized that the addition of a saddle block with intrathecal morphine would yield clinically important analgesic benefits. Detailed Description. PIV is ...

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.814538/full

Analgesic Efficacy of Spinal Morphine in Comparison With ... Spinal opioid and abdominal field block have been investigated as effective analgesia for postoperative pain and reduce the need for systemic medications and ...

5. janesthanalgcritcare.biomedcentral.com janesthanalgcritcare.biomedcentral.com/articles/10.1186/s44158-025-00235-0

Intrathecal morphine vs. Ultrasound-guided bilateral posterior ... Both ITM and posterior QLB provide effective postoperative analgesia in patients with CD, with comparable analgesic outcomes and side-effect profiles.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK499880/

Intrathecal Morphine - StatPearls - NCBI Bookshelf - NIH Intrathecal morphine is more likely to benefit patients with nociceptive or neuropathic pain that is well localized and responsive to systemic opioids.

7. associationofanaesthetists-publications.onlinelibrary.wiley.com associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.15569

Efficacy and safety of intrathecal morphine for analgesia after ... There is good evidence that intrathecal morphine provides effective analgesia after lower limb arthroplasty, without an increased risk of respiratory ...

8. mdpi.com mdpi.com/1424-8247/18/4/512

Intrathecal Morphine Versus Other Techniques for ... Conclusions: This meta-analysis was unable to demonstrate any significant benefit to postoperative pain relief with the use of ITM but may suggest that it is as ...

9. journals.lww.com journals.lww.com/md-journal/fulltext/2017/12010/perioperative_analgesia_after_intrathecal_fentanyl.56.aspx

Perioperative analgesia after intrathecal fentanyl and... It has been shown that morphine can provide postoperative analgesia for up to 24 hours, and a dose of up to 100 μg is relatively safe in patients undergoing CS.