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HypospadiasNCT02851290

Effect of Caudal and Penile Block on Hypospadias Repair Complications

A study testing Caudal block anesthesia and Dorsal penile nerve block anesthesia in people with Hypospadias, run by Baylor College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hypospadias is one of the most common genitourinary (GU) malformations, seen in approximately 1 of 250 male live births. Common methods of local anesthesia administration for hypospadias surgery include caudal and dorsal penile nerve blocks. Read more about this study

Who is it for?
Ages 4 months to 4 years, men only
Conditions the study is for
Hypospadias
What is being tested?
Caudal block anesthesia and Dorsal penile nerve block anesthesia
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
Jul 2016to 19 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 months to 4 years
  • Men only
  • No healthy volunteers
  • Child

Who may be able to join

  • Age 4 months to 4 years
  • ASA score I and II
  • Primary hypospadias repair in one stage including distal, midshaft, and proximal repairs

Who cannot join

  • Age <4 months or >4 years
  • ASA score >II
  • Genetic syndromes
  • Previous hypospadias operations
  • Staged hypospadias repair operations
  • Spinal dysraphism or other contraindications to caudal block
Show all 9Show fewer
  • Infection at the block site
  • Refusal of consent by the parents
  • Unwillingness of the anesthesiologist or surgeon to participate

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Texas Children's Hospital

    Houston, Texas, 77030

Other trials in United States

About this study

Hypospadias is one of the most common genitourinary (GU) malformations, seen in approximately 1 of 250 male live births. Common methods of local anesthesia administration for hypospadias surgery include caudal and dorsal penile nerve blocks. While both methods are known to be effective with minimal risk, the effect on post-operative complications is not well-established. The purpose of this randomized controlled trial is to evaluate if caudal versus dorsal penile nerve block results in higher rates of post-operative complications.

Read the detailed description

Hypospadias is a one of the most common genitourinary (GU) malformations, seen in approximately 1 of 250 male live births, characterized by proximal location of the urethral meatus, dorsal hooded foreskin with incomplete ventral fusion, and ventral curvature of the penis. Hypospadias repair includes several standard steps including urethroplasty, mobilization of adjacent flaps for urethroplasty coverage, rotation of penile skin flaps and circumcision. In order for the surgeon to operate in a clean and relatively bloodless field, tourniquets and local epinephrine injection have been used. In a rabbit hypospadias repair model, the authors used both tourniquet and local epinephrine infiltration to maintain a clear surgical field, and showed increased apoptotic urethral myocytes on TUNNEL assay and collagen deposition in the epinephrine cohort. The study also showed structural changes in the mitochondria on scanning electron microscopy in the epinephrine cohort. This is the only hypospadias study demonstrating pathologic changes in the urethra after tourniquet or epinephrine injection. While single stage hypospadias surgical techniques have standardized significantly over the two decades, surgical complications can still occur in up to 28% of patients. Complications include urethrocutaneous fistulas, meatal stenosis, glans dehiscence, urethral strictures, and urethral diverticulum. Risk factors for hypospadias surgical complications have been extensively published and include: proximal urethral location, previous operation, glans width <14 mm, no urethroplasty coverage layers, surgeon learning curve, and age <4 years old.

The majority of hypospadias surgical complications need to be revised surgically and this results in significant financial and emotional burden for the family. The financial impact of hypospadias visits, repairs, and reoperations on society is largely unknown. A single study in 2000 noted that $16.6 million was spent on operative and outpatient hypospadias care and 17,000 total outpatient hypospadias visits were made that year. No recent studies are available and the cost to the patient per surgery and per surgical complication repair is also unknown. Multiple objective hypospadias surgical questionnaires have been developed to characterize postoperative appearance of the skin, meatus, urinary stream, and presence of fistula. These studies have only been validated by the same institution and data correlating questionnaire scores to complications is sparse.

Penile sensation is derived primarily from the dorsal nerve of the penis. Ventrally there is some innervation to the frenulum that is derived from the perineal nerve branches. The dorsal nerve of the penis is a branch of the pudendal nerve which is supplied from sacral nerves. Common methods for penile block, which are performed by the hypospadias surgeon, include dorsal nerve penile block (DNPB) or penile ring block. The DNPB involves infiltration of local anesthetic using a short beveled needle in the subpubic location at the 10 and 2 o'clock positions such that the dorsal nerve of the penis is blocked as it enters the base of the penis. The penile ring block is performed by infiltration of local anesthetic in the subcutaneous tissue at the base of the penis. One prospective study showed that DNPB was significantly better than ring block. Success rates of DNPB have been noted to be anywhere from 90-100% in children undergoing circumcision. Complications from DNPB are exceptionally rare at <0.1% including hematoma and local tissue edema.

Caudal block is a commonly performed regional block by anesthesiologists for hypospadias surgery. It involves blockade of the same nerve pathway described above, at a more proximal location, by infiltration of the caudal epidural space through the sacral hiatus. The procedure is performed usually in the lateral position. Anatomic landmarks are defined by an equilateral triangle formed by the bilateral posterior superior iliac spines, and the sacral hiatus. Initially a short beveled needle or small gauge angiocatheter is inserted into the sacral hiatus at a 45 degree angle and then once a "pop" is heard, the angle is "dropped" to 0 degrees and the needle is advanced. Aspiration is performed and in the absence of cerebrospinal fluid or blood, a local anesthetic is injected. Complications are exceptionally rare at the rate of <0.003% and include local anesthetic toxicity, neurological injury or infection and success rates of up to 96% have been reported.

Penile physiology and blood flow parameters after DNPB and caudal block are largely unknown. Very few studies show the effects of distal organ perfusion after regional blockade. One study looking at children undergoing caudal block for urologic procedures found that caudal block using 1.5 ml/kg of 0.15% ropivicaine increased the dorsalis pedis arterial parameters: increased peak velocity 24%, volume flow 76%, arterial diameter 20%. The authors proposed a sympatholytic mechanism as the reason for these physiologic changes. Another randomized controlled trial primarily looking at post-operative pain outcomes in hypospadias repair patients also found increased penile volumes of 27% in the caudal block arm, with the proposed mechanism also being sympatholytic. Finally, there have been case reports in which the sympatholytic effects of caudal blocks are used to treat glans ischemia after circumcision.

Penile analgesia after caudal block is approximately equal to that of DNPB. A meta-analysis of the circumcision analgesia literature, analyzing over 700 patients showed analgesic equivalence of caudal versus parenteral analgesia. Also in the meta-analysis, caudal block was found to be equivalent to DNPB with increased motor blockade found in the caudal block arm. One randomized controlled trial assessing analgesia requirements in children undergoing hypospadias repair after caudal block and penile block found that penile block resulted in superior pain control. However, another randomized controlled trial found that caudal block resulted in superior pain control as compared to penile block. After either bock, there are usually no significant alterations in mean arterial pressure.

Recently, the association between caudal block and hypospadias surgical complications has been theorized and has drawn international interest amongst pediatric urologists and anesthesiologists. A randomized controlled trial of 54 distal hypospadias repair patients, half assigned to caudal block and half to penile block, showed that all urethrocutaneous fistulas were seen in the caudal block arm. Even though the primary outcome was post-operative pain control between the groups, the authors theorized that caudal blocks lead to sympathetic blockade, penile engorgement, tissue edema, and increased hypospadias surgical complications. A nested case control series comparing 45 fistulas and 90 controls showed no association between fistulas and caudal block. The authors found fistula to be associated with proximal urethral location, penile epinephrine injection, and longer operative times. Unpublished data presented at the 2015 American Urologic Association in New Orleans by Routh et al. showed that in a retrospective single surgeon series of 452 primary hypospadias repair patients, half which had caudal block and half which had penile block, caudal blockade was highly associated with hypospadias surgical complications even after adjusting for operative time (OR 3.9 (1.3-12.1)); p= 0.0008. This is the only study to date that has been powered appropriately to assess the association between caudal block and hypospadias complications. Thus, there is clinical equipoise regarding the utilization of caudal block versus penile block for post-operative pain control and also in minimizing surgical complications in hypospadias repair.

Conditions
Hypospadias
Being tested
Caudal block anesthesia, Dorsal penile nerve block anesthesia
Keywords
Hypospadias, Caudal block, Dorsal penile nerve block, Anesthesia, Urethrocutaneous fistula, Urethral stricture, Meatal stenosis, Glanular dehiscence
Medical subject headings
Hypospadias, Urethral Stricture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caudal block anesthesiaProcedure or surgery

    After induction of general anesthesia, a caudal block will be performed using 0.75-1 mL/kg of 0.2% ropivacaine without epinephrine

  • Dorsal penile nerve block anesthesiaProcedure or surgery

    After induction of general anesthesia, a dorsal penile nerve block will be performed using 0.75-1 mL/kg of 0.2% ropivacaine without epinephrine

Study groups in NCT02851290
Study groupRoleWhat they receive
Caudal blockExperimentalLocal anesthetic will be administered into the caudal space
Receives: Procedure: Caudal block anesthesia
Dorsal penile nerve blockActive comparatorLocal anesthetic will be administered around the dorsal penile nerve
Receives: Procedure: Dorsal penile nerve block anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-operative hypospadias repair complications

    Post-operative follow-up to evaluate for post-operative complications including urethrocutaneous fistula, glans dehiscence, meatal stenosis, and urethral stricture

    Measured: 24 months post-operatively

Secondary outcomes (3)
  1. Post-operative hypospadias repair pain

    Post-operative pain will be assessed using the FLACC scale (faces, legs, activity, cry and consolability scale)

    Measured: 1 hour post-operatively

  2. Caudal block-related complications

    Complications related to caudal block

    Measured: 1 hour post-operatively

  3. Dorsal penile nerve block-related complications

    Complications related to dorsal penile nerve block

    Measured: 1 hour post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2016 (estimated)
  2. Study startJul 2016
  3. Primary completion19 May 2023
  4. Study completion19 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02851290
Sponsor's protocol ID
H-38540
Status last verified
May 2023
First submitted
28 Jul 2016
Last updated
22 May 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Caudal block anesthesia and Dorsal penile nerve block anesthesia in people with Hypospadias, run by Baylor College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-operative hypospadias repair complications (time frame: 24 months post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.

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