Pudendal vs Caudal Block for Pediatric Penile Surgery

Overseen By Al McAuley

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must not be taking: Analgesics

Disqualifiers: ASA ≥ 3, Renal insufficiency, others

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

Compensation: Varies

Number of Visits: 2

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The study will compare recovery profile in children receiving pudendal blocks vs caudal analgesia for ambulatory circumcision or hypospadias repair in children between 6 months and 2 years. The subjects of the study will be randomized to receive either a caudal or a pudendal block.

Will I have to stop taking my current medications?

The trial requires that participants do not use any pain medications (like opioids, acetaminophen, or NSAIDs) within 24 hours before surgery.

What data supports the effectiveness of the treatment Caudal Block, Caudal Epidural Block, Caudal Anesthesia, Caudal Nerve Block, Pudendal Block, Pudendal Nerve Block, Pudendal Block, Saddle Block for pediatric penile surgery?

Research suggests that while caudal blocks are commonly used for pediatric penile surgeries, they may have complications, and pudendal nerve blocks are considered an effective alternative with similar pain control outcomes and a lower risk profile. ^{1 2 3 4 5}

Is the caudal block safe for children undergoing surgery?

Caudal blocks are commonly used in children for surgery and are generally considered safe, but some studies have noted concerns about complications. A large study of 18,650 caudal blocks found them to be safe, though other research suggests there can be issues like motor blockade (temporary muscle weakness) and rare severe complications. ^{3 6 7 8 9}

How does the caudal block treatment differ from other treatments for pediatric penile surgery?

Caudal block is a common treatment for pediatric penile surgeries, providing longer-lasting pain relief compared to alternatives like penile block, but it has a higher risk of complications such as motor blockade. Pudendal nerve block is an effective alternative with fewer complications, making it a safer option for some patients. ^{3 4 8 10 11}

Research Team

Leili Khorassani, MD

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for children aged 6 months to 3 years who need outpatient circumcision or hypospadias repair. It's not for kids with spinal issues, a history of heavy painkiller use, kidney problems, bleeding disorders, other surgeries at the same time, wards of the state, non-English speakers or if their caregiver can't follow home instructions.

Inclusion Criteria

My child, aged 6 months to 3 years, is scheduled for circumcision or hypospadias repair.

Exclusion Criteria

being a ward of the state

I have been diagnosed with complex regional pain syndrome.

inability of the primary caregiver to comply with home instructions

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Surgery and Immediate Recovery

Participants undergo surgery with either a caudal or pudendal block, followed by immediate recovery in the PACU where pain scores and analgesic consumption are recorded.

1 day

1 visit (in-person)

Home Recovery and Monitoring

Caregivers monitor and record pain scores at home using the Pain Journal. A phone call is made 24-48 hours post-discharge to collect data and check on the child's health status.

2 weeks

1 phone call

Follow-up

Participants are monitored for late complications and adverse events through follow-up surgical notes and additional phone calls if necessary.

2 weeks

Treatment Details

Interventions

• Caudal Block
• Pudendal Block

Trial Overview The study compares two types of anesthesia: pudendal block and caudal block in young children having penile surgery. Kids will be randomly chosen to receive one type of block to see which one helps them recover better after surgery.

Participant Groups

Group I: Caudal block Active Control 1 Intervention

This group will receive the Caudal block during their operation (50 patients circumcision, 50 patients hypospadias). This group consist of 100 subjects

Group II: Pudendal Block Active Control 1 Intervention

This group will receive the Pudendal block during their operation (50 patients circumcision, 50 patients hypospadias). This group consist of 100 subjects

Caudal Block is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Caudal Block for:

• Pediatric surgical anesthesia
• Chronic pain management

Approved in United States as Caudal Block for:

• Pediatric surgical anesthesia
• Chronic pain management
• Postoperative analgesia

Approved in Canada as Caudal Block for:

• Pediatric surgical anesthesia
• Chronic pain management

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Findings from Research

Pudendal nerve block (PNB) is a safer alternative to caudal epidural analgesia (CEA) for managing pain in pediatric penile surgeries, with a lower risk of complications.

PNB has been shown to provide similar postoperative pain control outcomes compared to CEA, making it an effective option for perioperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How I Do It: The pudendal nerve block for pediatric ambulatory urologic surgery. Okoro, C., Cannon, S., Low, D., et al.[2021]

In a study of 192 patients undergoing distal hypospadias repair, those who received caudal anesthesia had a significantly higher risk of postoperative complications, specifically a risk ratio of 3.70 for complications compared to those who received a penile block.

The findings suggest that caudal anesthesia may lead to more complications, such as fistula formation, than penile block, highlighting the importance of anesthesia choice in surgical outcomes for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can regional anesthesia have an effect on surgical outcomes in patients undergoing distal hypospadia surgery? Saavedra-Belaunde, JA., Soto-Aviles, O., Jorge, J., et al.[2022]

The ultrasound-guided dorsal penile nerve block (DPNB) is a safe and effective alternative to the traditional caudal block for pediatric circumcision surgeries, as shown in a study involving 104 patients.

Patients receiving DPNB experienced a longer duration before needing analgesics and had a shorter time to first micturition compared to those receiving a caudal block, with fewer instances of lower limb numbness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dorsal Penile Nerve Block via Perineal Approach, an Alternative to a Caudal Block for Pediatric Circumcision: A Randomized Controlled Trial. Wang, X., Dong, C., Beekoo, D., et al.[2022]

In a study of 999 pediatric patients undergoing various penile surgeries, pudendal nerve blocks (PNB) were found to provide equivalent postoperative pain control compared to caudal epidural analgesia (CEA), with no significant differences in pain scores, morphine rescue rates, or length of stay in the post-anesthesia care unit.

PNB, particularly landmark-directed PNB, is suggested as a safer and simpler alternative to CEA for pediatric urology procedures, potentially reducing the risk of complications associated with CEA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pudendal nerve block for ambulatory urology: What's old is new again. A quality improvement project. Okoro, C., Huang, H., Cannon, S., et al.[2021]

In a study of 25 male patients undergoing high-dose-rate brachytherapy for prostate cancer, bilateral pudendal nerve block (NPB) was found to be a safe and effective alternative to combined spinal-epidural anesthesia (CSE), with all patients preferring NPB for pain management.

The NPB resulted in low pain scores during and after the procedure (1.4 and 1.08 on a scale of 1-10), allowed for better postoperative mobility, and had no reported complications, making it a practical option that can be easily learned by urologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pudendal nerve block in HDR-brachytherapy patients: do we really need general or regional anesthesia? Schenck, M., Schenck, C., Rübben, H., et al.[2021]

In a study of 18,650 children receiving caudal blocks, the overall incidence of complications was low at 1.9%, with the most common issues being block failure and intravascular injection.

No serious long-term complications were reported, and safety concerns can be managed by carefully selecting appropriate dosages of local anesthetics, as 24.6% of subjects received potentially unsafe doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are caudal blocks for pain control safe in children? an analysis of 18,650 caudal blocks from the Pediatric Regional Anesthesia Network (PRAN) database. Suresh, S., Long, J., Birmingham, PK., et al.[2022]

In a study involving 66 pediatric patients undergoing perineal surgeries, adding clonidine to levobupivacaine in a caudal block significantly prolonged postoperative analgesia compared to using tramadol or levobupivacaine alone.

The addition of clonidine did not result in any clinically significant side effects, making it a safer and more effective option for enhancing pain relief in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Study of Tramadol and Clonidine as an Additive to Levobupivacaine in Caudal Block in Pediatric Patients Undergoing Perineal Surgeries. Rawat, J., Shyam, R., Kaushal, D.[2022]

In a study of 38 boys undergoing circumcision, both caudal extradural blockade and penile block provided similar levels of postoperative pain relief, assessed over the first 7 hours after surgery.

The penile block had a lower incidence of motor blockade compared to the caudal block, making it a safer alternative for analgesia in this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Penile block for circumcision? A comparison with caudal blockade. Yeoman, PM., Cooke, R., Hain, WR.[2019]

In a study involving 60 children aged 3-6 years undergoing urogenital surgeries, dexamethasone administered caudally significantly prolonged postoperative analgesia to an average of 626.33 minutes compared to just 194.67 minutes when given intravenously.

The use of caudal dexamethasone also reduced the need for additional analgesics on the first postoperative day, indicating its effectiveness as an adjuvant in enhancing pain management after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Analgesic Efficacy of Caudal Dexamethasone with Intravenous Dexamethasone as an Adjuvant to Caudal Block in Pediatric Patients Undergoing Urogenital Surgeries. Dongare, DH., Karhade, SS.[2022]

In a study of 50 healthy boys aged 2 to 12 undergoing circumcision, caudal epidural blockade provided longer-lasting pain relief compared to penile ring block, with a significant difference in analgesia duration (P = 0.003).

While both techniques were effective, the penile ring block had an 8% failure rate but was associated with no local or systemic complications, making it a safer option with fewer adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of subcutaneous ring block of the penis with caudal epidural block for post-circumcision analgesia in children. Irwin, MG., Cheng, W.[2019]

In a study of 100 boys aged 3 to 8 undergoing circumcision, both penile and caudal blocks provided effective post-operative pain relief without serious complications, making them safe options for analgesia.

The penile block resulted in a shorter induction-incision time and allowed for earlier discharge compared to the caudal block, suggesting it may be more efficient in a clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is penile block better than caudal epidural block for postcircumcision analgesia? Weksler, N., Atias, I., Klein, M., et al.[2006]

References

1. Canada pubmed.ncbi.nlm.nih.gov

How I Do It: The pudendal nerve block for pediatric ambulatory urologic surgery. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Can regional anesthesia have an effect on surgical outcomes in patients undergoing distal hypospadia surgery? [2022]

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

Dorsal Penile Nerve Block via Perineal Approach, an Alternative to a Caudal Block for Pediatric Circumcision: A Randomized Controlled Trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The pudendal nerve block for ambulatory urology: What's old is new again. A quality improvement project. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Pudendal nerve block in HDR-brachytherapy patients: do we really need general or regional anesthesia? [2021]

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

Are caudal blocks for pain control safe in children? an analysis of 18,650 caudal blocks from the Pediatric Regional Anesthesia Network (PRAN) database. [2022]

7. India pubmed.ncbi.nlm.nih.gov

A Comparative Study of Tramadol and Clonidine as an Additive to Levobupivacaine in Caudal Block in Pediatric Patients Undergoing Perineal Surgeries. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Penile block for circumcision? A comparison with caudal blockade. [2019]

9. India pubmed.ncbi.nlm.nih.gov

Comparison of Analgesic Efficacy of Caudal Dexamethasone with Intravenous Dexamethasone as an Adjuvant to Caudal Block in Pediatric Patients Undergoing Urogenital Surgeries. [2022]

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

Comparison of subcutaneous ring block of the penis with caudal epidural block for post-circumcision analgesia in children. [2019]

11. Japan pubmed.ncbi.nlm.nih.gov

Is penile block better than caudal epidural block for postcircumcision analgesia? [2006]